trends of chronic diseases and partnership between big...
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Trends of chronic diseases
and partnership between
Big Pharma and Patient
Associations
Towards which direction the pharmaceuticals world is going ?
who must interface with and what are the key stakeholders to
consider in this new reality?
PROJECT WORK – FONDAZIONE ISTUD – “SCIENZIATI IN
AZIENDA” XIV EDITION
Letizia Armenio, Marika Bianco, Eleonora Di Paolo, Elisa Oliva,
Teresa Petillo, Mariangela Pierro.
14/12/2013
Sommario
1 ABSTRACT .........................................................................................................................................................5
2 RIASSUNTO .......................................................................................................................................................7
3 INTRODUCTION: THE SCENARIO .......................................................................................................................9
3.1 FACE TO FACE WITH CRONIC DISEASE ......................................................................................................9
3.1.1 The Causes Of Chronic Diseases .................................................................................................... 10
3.1.2 Risk Accumulation ......................................................................................................................... 12
3.1.3 Underlying Determinants .............................................................................................................. 12
3.1.4 The Health Impact Of The Main Risk Factors ................................................................................ 15
3.1.5 Projections Of Future Deaths ........................................................................................................ 15
3.2 THE ECONOMIC IMPACT OF CHRONIC DISEASES .................................................................................. 16
3.2.1 Linkages Between Disease And The Economy ............................................................................... 17
3.2.2 The Full Costs Of Chronic Diseases For Countries ......................................................................... 18
3.3 WHO: THE EVIDENCE FOR ACTION ........................................................................................................ 20
4 THE INFLUENCE ON PHARMACEUTICAL MARKET ......................................................................................... 22
4.1 ACTIONS AND REACTIONS OF BIG PHARMAS........................................................................................ 22
4.2 A NEW OUTLOOK: THE PATIENT CENTRICITY ........................................................................................ 24
4.3 PATIENT ASSOCIATIONS ........................................................................................................................ 28
4.3.1 Who Are The Patient Groups? ....................................................................................................... 28
4.3.2 What Do The Patient Groups Do? ................................................................................................. 28
4.3.3 How Do Patient Groups Communicate With Citizens: The Web Power........................................ 30
4.3.4 The Role Of Patient Groups In Italy ............................................................................................... 33
4.4 PATIENT ASSOCIATIONS AND PHARMACEUTICAL INDUSTRIES: THE GUIDELINES ................................ 35
5 FIELD RESEARCH: OUR INVESTIGATION......................................................................................................... 40
5.1 EMPOWERMENT ACTIONS .................................................................................................................... 40
5.1.1 Patient Advocacy: “The Voice Of Who Did Not Have The Voice”.................................................. 43
5.1.2 Pfizer And The Encourage Of “Viverla Tutta” ................................................................................ 52
5.2 THE POINT OF VIEW OF PHARMACEUTICAL COMPANIES: OUR INTEVIEWS ......................................... 60
5.3 THE PEOPLE OPINION: OUR SURVEY ..................................................................................................... 62
6 CRITICAL ISSUES AND STRENGTHS: OUR VIEWS ............................................................................................ 65
7 ACKNOWLEDGEMENT ................................................................................................................................... 68
8 BIBLIOGRAPHY ............................................................................................................................................... 69
1 ABSTRACT
Currently, chronic diseases, such as diabetes, cancer and cardiovascular diseases are the
cause of an increasing number of deaths all over the world and this is a priority for public
health, both globally and locally.
They represent a deep economic burden on individuals, health systems and societies, and
these costs are expected to rise without the implementation of effective interventions.
For this reason, the World Health Organization has repeatedly stressed that it is
necessary to invest in the prevention and control of these diseases, working in an
interdisciplinary manner, with a joint plan and an integrated approach.
In this new scenario, the pharmaceutical market has to face many and substantial
changes and the stakeholders which must be taken into account are numerous.
The main one is definitely the patient, who has assumed a crucial role in the
management of the disease: the empowerment of the patient suffering from a chronic
disease is in fact essential, since if a patient educated and informed could more easily
achieve a better quality of life.
“Patient-centricity” thus became a central theme, which involved numerous
pharmaceutical companies and exhorted them to interface directly with the patient and
his unmet medical needs, in order to incorporate the point of view of their business “end-
user” within corporate strategies.
In this partnership patients' associations hold a fundamental position: in fact the interest
of the pharmaceutical industry can not only result in mere financial support, but it can be
an opportunity of growth and improvement in responding to the needs of patients.
Due to the increasingly strong interaction between these two realities, the formulation of
specific directives and guidelines related to transparency and good practice became
necessary to better regulate these collaborations.
Many initiatives, projects and campaigns were born to support the patient through these
partnerships, but the path taken seems to be far and manifold.
Therefore, the present research work, carried out at the ISTUD Foundation under the
program “Scientist in the Company” XIV edition, has the aim of deepening our
understandings on how pharmaceutical business reality is orienting its strategies and
which future objectives could be pursued, identifying critical issues and strengths of this
rapidly changing environment.
2 RIASSUNTO
Attualmente le malattie croniche, come diabete, tumori e patologie cardiovascolari, sono
causa di un numero sempre più elevato di decessi in tutto il mondo e per questo
costituiscono una priorità per la salute pubblica, sia a livello globale che locale.
Esse rappresentano un profondo onere economico per gli individui, i sistemi sanitari e le
società e tali costi sono destinati ad aumentare senza l'attuazione di interventi efficaci.
Per questo l’Organizzazione Mondiale della Sanità ha più volte sottolineato come sia
necessario investire nella prevenzione e nel controllo di queste malattie, agendo in
maniera interdisciplinare, con un piano congiunto ed un approccio integrato.
In questo nuovo scenario molti e sostanziali sono i cambiamenti che il mercato
farmaceutico deve affrontare e numerosi gli stakeholders di cui deve tener conto.
Il principale è sicuramente il paziente, che ha assunto un ruolo cruciale nella gestione
della malattia: l’empowerment del malato cronico risulta infatti essenziale, poiché la
persona, se formata e informata, può raggiungere più facilmente una migliore qualità
della vita.
Ed è proprio il focus sulla centralità del paziente che ha interessato e spinto numerose
aziende farmaceutiche a volersi interfacciare in maniera diretta con il malato e con i suoi
unmet medical needs, per poter incorporare il punto di vista dell’ utente finale del proprio
business all’interno di strategie istituzionali.
In questo rapporto, le associazioni di pazienti ricoprono una posizione fondamentale: per
queste organizzazioni infatti l’interesse dell’industria farmaceutica può non tradursi solo
in mero sostegno finanziario, ma può rappresentare un’occasione di crescita e
miglioramento nella risposta ai bisogni dei pazienti.
Data quindi l’interazione sempre più forte tra queste due realtà si è resa necessaria la
formulazione di norme precise legate alla trasparenza e di manuali di buona condotta,
oltre alla creazione di aree e competenze specifiche per regolamentare al meglio queste
collaborazioni.
Numerose sono le iniziative, i progetti e le campagne a supporto del paziente portate a
termine grazie a partnership di questo tipo, ma la strada intrapresa sembra essere
ancora lunga e articolata.
Pertanto, con il presente lavoro di ricerca, svolto nell’ambito del programma Scienziati in
Azienda XIV edizione presso la Fondazione ISTUD, ci siamo poste l’obiettivo di
approfondire e comprendere come le realtà legate al mondo farmaceutico stiano
orientando le proprie strategie e quali obiettivi futuri potrebbero essere perseguiti,
individuando le criticità e i punti di forza di questo contesto in continua evoluzione.
3 INTRODUCTION: THE SCENARIO
3.1 FACE TO FACE WITH CRONIC DISEASE
The lives of far too many people in the world are being blighted and cut short by chronic
diseases such as heart disease, stroke, cancer, chronic respiratory diseases and diabetes.
There are many other chronic conditions and diseases that contribute significantly to the
burden of disease on individuals, families, societies and countries. Examples include
mental disorders, vision and hearing impairment, oral diseases, bone and joint disorders,
and genetic disorders.
This is no longer only happening in high income countries. Four out of five chronic
disease deaths today are in low and middle income countries. People in these countries
tend to develop diseases at younger ages, suffer longer, often with preventable
complications and die sooner than those in high income countries.
Globally, of the 58 million deaths in 2005, approximately 35 million will be as a result of
chronic diseases. They are currently the major cause of death among adults in almost all
countries and the toll is projected to increase by a further 17% in the next 10 years. At
the same time, child overweight and obesity are increasing worldwide, and incidence of
type 2 diabetes is growing.
This is a very serious situation, both for public health and for the societies and economies
affected.
Until recently, the impact and profile of chronic disease has generally been insufficiently
appreciated. It is clear the actual scale and severity of the problem and the urgent need
for action. The cost of inaction is clear and unacceptable.
Through investing in vigorous and well-targeted prevention and control now, there is a
real opportunity to make significant progress and improve the lives of populations across
the globe.
3.1.1 The Causes Of Chronic Diseases
The evidence on the causes of the chronic diseases comes from a full range of studies –
laboratory, clinical and population-based – conducted in all regions of the world. The
causes (risk factors) of chronic diseases are known; a small set of common risk factors
are responsible for most of the main chronic diseases and these risk factors are the same
in men and women and in all regions.
The most important modifiable risk factors are:
• unhealthy diet and excessive energy intake;
• physical inactivity;
• tobacco use.
These causes are expressed through the intermediate risk factors of raised blood
pressure, raised glucose levels, abnormal blood lipids (particularly low density lipoprotein
– LDL cholesterol), overweight (body mass index ≥25 kg/m2) and obesity (body mass
index ≥30 kg/m2).
The major modifiable risk factors, in conjunction with the non-modifiable risk factors of
age and heredity, explain the majority of new events of heart disease, stroke, chronic
respiratory diseases and some important cancers. The relationship between the major
modifiable risk factors and the main chronic diseases is similar in all regions of the world.
For example eight risk factors (alcohol use, tobacco use, high blood pressure, high body
mass index, high cholesterol, high blood glucose, low fruit and vegetable intake, and
physical inactivity) account for 61% of cardiovascular deaths. Combined, these same risk
factors account for over three quarters of ischemic heart disease: the leading cause of
death worldwide.
Picture 1 – from the WHO report
Although these major risk factors are usually associated with high-income countries, over
84% of the total global burden of disease they cause occurs in low- and middle-income
countries. Reducing exposure to these eight risk factors would increase global life
expectancy by almost 5 years.
Nine environmental and behavioural risks, together with seven infectious causes, are
responsible for 45% of cancer deaths worldwide. For specific cancers, the proportion is
higher: for example, tobacco smoking alone causes 71% of lung cancer deaths
worldwide. Tobacco accounted for 18% of deaths in high-income countries.
Health risks are in transition: populations are ageing owing to successes against
infectious diseases; at the same time, patterns of physical activity and food, alcohol and
tobacco consumption are changing. Low- and middle-income countries now face a double
burden of increasing chronic, noncommunicable conditions, as well as the communicable
diseases that traditionally affect the poor. Understanding the role of these risk factors is
important for developing clear and effective strategies for improving global health.
3.1.2 Risk Accumulation
Ageing is an important marker of the accumulation of modifiable risks for chronic
disease: the impact of risk factors increases over the life course. A key lesson from many
wealthy countries is that it is possible to delay deaths from chronic diseases by several
decades, thereby avoiding deaths among middle-aged people. Successful interventions in
middle and older age will reap major short-term benefits. In the longer term,
interventions early in life have the potential to reduce substantially the chronic
disease pandemic.
3.1.3 Underlying Determinants
The underlying determinants of chronic diseases – the “causes of the causes” – are a
reflection of the major forces driving social, economic and cultural change – globalization,
urbanization, population ageing, and the general policy environment. Globalization refers
to the increasing interconnectedness of countries and the openness of borders to ideas,
people, commerce and financial capital. Globalization drives chronic disease population
risks in complex ways, both directly and indirectly. The health-related advantages of
Picture 2 – from the WHO report
globalization include the introduction of modern technologies, such as information and
communication technologies for health-care systems.
The negative health-related effects of globalization include the trend known as the
“nutrition transition”: populations in low and middle income countries are now consuming
diets high in total energy, fats, salt and sugar. The increased consumption of these foods
in these countries is driven partly by shifts in demand-side factors, such as increased
income and reduced time to prepare food. Supply-side determinants include increased
production, promotion and marketing of processed foods and those high in fat, salt and
sugar, as well as tobacco and other products with adverse effects on population health
status. A significant proportion of global marketing is now targeted at children and
underlies unhealthy behaviour.
The widespread belief that chronic diseases are only “diseases of affluence” is incorrect.
Chronic disease risks become widespread much earlier in a country’s economic
development than is usually realized.
For example, population levels of body mass index and total cholesterol increase rapidly
as poor countries become richer and national income rises. They remain steady once a
certain level of national income is reached, before eventually declining (see next
chapter).
In the second half of the 20th century, the proportion of people in Africa, Asia and Latin
America living in urban areas rose from 16% to 50%. Urbanization creates conditions in
which people are exposed to new products, technologies, and marketing of unhealthy
goods, and in which they adopt less physically active types of employment. Unplanned
urban sprawl can further reduce physical activity levels by discouraging walking or
bicycling.
As well as globalization and urbanization, rapid population ageing is occurring worldwide.
The total number of people aged 70 years or more worldwide is expected to increase
from 269 million in 2000 to 1 billion in 2050. High income countries will see their elderly
population (defined as people 70 years of age and older) increase from 93 million to 217
million over this period, while in low and middle income countries the increase will be
174 million to 813 million – more than 466%.
The general policy environment is another crucial determinant of population health.
Policies by central and local government on food, agriculture, trade, media advertising,
transport, urban design and the built environment shape opportunities for people to
make healthy choices. In an unsupportive policy environment it is difficult for people,
especially those in deprived populations, to benefit from existing knowledge on
The causes and prevention of the main chronic diseases.
3.1.4 The Health Impact Of The Main Risk Factors
The contribution of risk factors to death and disease is estimated by calculating the
current “attributable” mortality and burden of disease (DALYs) caused by past exposure
to the main risk factors over and above the minimum possible risk factor exposure.
Chronic disease risk factors are a leading cause of the death and disease burden in all
countries, regardless of their economic development status. The leading risk factor
globally is raised blood pressure, followed by tobacco use, raised total cholesterol, and
low fruit and vegetable consumption. The major risk factors together account for around
80% of deaths from heart disease and stroke.
Each year at least:
• 4.9 million people die as a result of tobacco use;
• 1.9 million people die as a result of physical inactivity;
• 2.7 million people die as a result of low fruit and vegetable consumption;
• 2.6 million people die as a result of being overweight or obese;
• 7.1 million people die as a result of raised blood pressure;
• 4.4 million people die as a result of raised total cholesterol levels.
Further analyses using 2002 death estimates show that among the nine selected
countries, the proportion of deaths from all causes of disease attributable to raised
systolic blood pressure (greater than 115 mm Hg) is highest in the Russian Federation
with similar patterns in men and women, representing more than 5 million years of life
lost. A similar picture emerges when the contribution of the risk factors to the burden
of disease (DALYs) is estimated.
3.1.5 Projections Of Future Deaths
In general, deaths from chronic diseases are projected to increase between 2005 and
2015, while at the same time deaths from communicable diseases, maternal and
perinatal conditions, and nutritional deficiencies combined are projected to decrease. The
projected increase in the burden of chronic diseases worldwide is largely driven by
population ageing, supplemented by the large numbers of people who are now exposed
to chronic disease risk factors.
There will be a total of 64 million deaths in 2015:
• 17 million people will die from communicable diseases, maternal and perinatal
conditions and nutritional deficiencies combined;
• 41 million people will die from chronic diseases;
• Cardiovascular diseases will remain the single leading cause of death, with an
estimated 20 million people dying, mainly from heart disease and stroke;
• Deaths from chronic diseases will increase by 17% between 2005 and 2015, from
35 million to 41 million.
3.2 THE ECONOMIC IMPACT OF CHRONIC DISEASES
Chronic diseases are a major cost and a profound economic burden to individuals, their
families, health systems and societies. These costs will increase without the
implementation of effective interventions.
Investment in interventions to control the burden of chronic diseases will bring
appreciable economic benefits.
Figura 3 – From the WHO Report
3.2.1 Linkages Between Disease And The Economy
Chronic diseases, deprive individuals of their health and productive potential. The burden
of chronic diseases may invariably challenge individual or household income and savings,
and compete with investment activities. From countries’ perspective, chronic diseases
reduce life expectancy and ultimately economic productivity, thus depleting the quality
and quantity of countries’ labour force. This may result into lower national output in
national income (GDP and GNI). There has been some description in the literature of how
diseases reduce intergenerational skills and wealth transfer.
In contrast, good health improves levels of human capital which may in turn, positively
affect individual productivity and ultimately affect economic growth rates. Workforce
productivity is increased by reducing incapacity, disability and workdays lost. Good
health also increases individuals’ economic opportunities and levels of education
(schooling and scholastic performance). Finally, good health frees resources, which would
otherwise be used to pay for treatment, and as such reduces the likelihood of poverty.
The economic impact of chronic diseases can be estimated and projected by analysing
specific channels through which chronic disease influences economies. However, income
earnings (e.g. GDP) provide the ultimate link to the socioeconomic effects of chronic
disease, hence are convenient outcome measures by which economic impact of chronic
diseases may be estimated.
Two possible approaches to exploring the economic impact of chronic diseases are: 1. the
cost perspective, that is, exploring the economic cost of failing to intervene; and 2. the
benefit perspective, that is., exploring the accruable gains from timely interventions.
Approaches to estimating economic impact of chronic diseases in the literature fall into
three main categories: (1) the cost of illness (COI) methods; (2) economic growth
(growth accounting) models which estimates cost of chronic diseases focusing on the
impact on human capital or on labour supply; and (3) through the full-income method
which adds the value of health gains (health income or welfare) to national income. The
majority of the studies on economic impact of chronic disease have employed the cost of
illness approach even though these are relatively few in contrast to the magnitude of
burden of chronic disease. To our knowledge, studies that used economic growth and the
full-income models to explore the economic impact of chronic diseases are rare, despite
the burden that they pose to countries and regions. The few studies that have explored
the impact of health on the economy have focused on AIDS(2-6), malaria and other
communicable diseases.
3.2.2 The Full Costs Of Chronic Diseases For Countries
The base estimates show that countries will potentially lose substantial amounts in
national income as a result of the impact of deaths from chronic disease on labour
supplies and savings. In 2005, the estimated loss in national income from heart disease,
stroke and diabetes are $18 billion dollars in China, $11 billion dollars in the Russian
Federation, $9 billion dollars in India, and $ 2.7 billion dollars in Brazil. Similarly, the
losses for UK, Pakistan, Canada, Nigeria and the United Republic of Tanzania are $1.6
billion, $1.2 billion, $ 0.53 billion $0.4 billion and $0.1 billion respectively.
These losses accumulate over time because each year, more people die. Estimates for
2015 for the same countries are between 3 and 7 times those of 2005. The cumulative
and average loss over the entire period is summarized in table 2. The dollar values of the
losses are obviously higher in the larger countries like China, India and the Russian
Federation, and are as high as $556 million dollars in China. By the same estimation,
Brazil, Pakistan and the United Kingdom and stand to lose between $30 billion and $49
billion over the same period. Nigeria and the United Republic of Tanzania are predicted to
stand to lose a cumulated $7.6 billion and $2.5 billion in national income between 2005
and 2015.
Countries like China, India and the Russian Federation stand to lose on average between
$23billion and $53 billion annually in forgone national income due to deaths from heart
disease, stroke and diabetes over 10 years between 2005 and 2015. These annual losses
are compared to Canada ($0.9 billion) , the United Kingdom ($3.4 billion), Pakistan ($3.5
billion) and Brazil ($5.1 billion).
The global goal proposes a target of 2% annual reduction in projected chronic disease
death rates between 2005 and 2015. This corresponds to preventing 36 million
premature deaths over the next 10 years, 17 million of which will be in people under 70
years of age. In the recent years it has been one of the most important World Health
Organization’s purpose.
3.3 WHO: THE EVIDENCE FOR ACTION
“We know what works, we know what it costs and we know
that all countries are at risk. We have an Action Plan to avert
millions of premature deaths and help promote a better
quality of life for millions more."
The World Health Organization in 2004 published a report, " Preventing chronic diseases:
a vital investment ", in which she argues that global action on chronic disease prevention
could save the lives of 36 million people who may otherwise death by 2015.
Currently, chronic diseases are the leading cause of death in the world: according to the
WHO report, about 17 million people die prematurely every year just because of a global
epidemic of chronic diseases. A number that continues to grow. A global epidemic that
must be stopped, according to the WHO, to avoid unnecessary suffering and premature
death to millions of people who suffer from cardiovascular disease, stroke, cancer and
diabetes.
Contrary to what is commonly believed, the epidemic is more dramatic in low- and
middle-income countries, where they occur 80% of all deaths from chronic disease. The
WHO report provides data for nine countries: Brazil, Canada, China, India, Nigeria,
Pakistan, Russia , Britain and Tanzania. In addition, it also gives new projections of the
economic impact of chronic diseases. For example, in China, India and Russia billions of
dollars could be lost over the next ten years due to these diseases. The estimate of total
losses, only in the case of China, between 2005 and 2015, amounted to 558 billion
dollars, 236 and 303 for India to Russia.
In its report, the WHO will place a new global goal: to reduce the estimated trend of
death from chronic disease by 2% each year until 2015. This reduction could prevent the
deaths of 36 million people over the next ten years, half of which would otherwise die
before the age of 70 years.
However, the resolution of these problems is not under the control of a single sector: it is
therefore necessary to involve all government departments, private industry, civil society
and communities, who need to collaborate together.
Moreover, working closely with Member States, WHO has developed “The 2008-2013
Action Plan for the Global Strategy for the Prevention and Control of Noncommunicable
Disease” to prevent chronic diseases from occurring and to help the millions who are
already affected to cope with these lifelong illnesses. This Action Plan, endorsed at the
Sixty-first World Health Assembly in May 2008, is based on the sound vision of the Global
Strategy for the Prevention and Control of Noncommunicable Diseases, endorsed at the
Fifty-third World Health Assembly in May 2000. It also aims to build on the WHO
Framework Convention on Tobacco Control and the WHO Global Strategy on Diet,
Physical Activity and Health.
The Action Plan provides Member States, WHO and the international community with a
roadmap to establish and strengthen initiatives for the surveillance, prevention and
management of NCDs.
Furthermore, the Plan highlights the pressing need to invest in NCD prevention as an
integral part of sustainable socioeconomic development. NCD prevention is an All-
Government responsibility. Considerably more gains can be achieved by influencing
policies of non-health sectors than by health policies alone. All stakeholders will
need to intensify and harmonize their efforts to avert these preventable conditions and to
save millions from suffering needlessly and dying prematurely.
The plan has the overall purpose of:
• mapping the emerging epidemics of noncommunicable diseases and analysing their
social, economic, behavioural and political determinants as the basis for providing
guidance on the policy, programmatic, legislative and financial measures that are needed
to support and monitor the prevention and control of noncommunicable diseases;
• reducing the level of exposure of individuals and populations to the common modifiable
risk factors for noncommunicable diseases – namely, tobacco use, unhealthy diet and
physical inactivity, and the harmful use of alcohol – and their determinants, while at the
same time strengthening the capacity of individuals and populations to make healthier
choices and follow lifestyle patterns that foster good health;
• strengthening health care for people with noncommunicable diseases by developing
evidence-based norms, standards and guidelines for cost-effective interventions and by
reorienting health systems to respond to the need for effective management of diseases
of a chronic nature.
4 THE INFLUENCE ON PHARMACEUTICAL MARKET
4.1 ACTIONS AND REACTIONS OF BIG PHARMAS
The R&D-based pharmaceutical industry recognizes the increasing burden that Non-
Communicable Diseases (NCDs) place on patients and health systems around the world.
In the fight to improve the health and quality of life of all patients, the pharmaceutical
industry is committed to continuing partnerships to tackle these complex issues including
extensive investment in R&D programs dedicated to the development of new NCD
preventative and treatment products. Both prevention and treatment play an important
role in increasing our ability to tackle NCDs.
In 2009, there were more than 6,700 compounds in development worldwide. Billions of
dollars are invested in research and development each year because only one of every
5,000 –10,000 compounds makes it to market. In the United States alone,
pharmaceutical companies spent $65.3 billion on research and development in 2009.
The innovation of the pharmaceutical industry has saved lives. In fact, between 1986 and
2000, a study of 52 countries showed an increase in life expectancy, and 40%–59% of
the increases were due to the introduction of innovative medicines.
Picture 4 – Increase in Life Expectancy
For example, interventions and appropriate use of medicines have resulted in declining
rates of death and heart failure resulting from cardiovascular disease. Figure xxx
illustrates the 45% decline that has occurred in 14 countries from heart attack deaths
and heart failure from 1999 to 2005.
Picture 5 – The Adverse Events
The pharmaceutical industry recognizes its role in combating NCDs worldwide with
appropriate interventions. Research and development have made interventions available
to address chronic diseases through drug therapies that effectively and safely treat
chronic diseases. In addition to creating new therapies, the pharmaceutical industry
understands that they should:
• Help developing countries to have access to NCD treatments and medicines
• Form partnerships with national leadership to create solutions for the problem of NCDs
• Promote workplace wellness programs to improve the health of employees.
The conclusion is that the pharmaceutical industry, is moving on the same direction of
the diseases. Mainly, the pharmaceutical environment needs huge economical
investments because the development of new compounds is quite expensive. From the
other side the patients that are suffering of chronic diseases, thanks to the
pharmaceutical innovation, can benefit of an improvement of the quality of life and the
death rate. This means that there is a reciprocal exchange between the pharmaceutical
industry and the patients.
4.2 A NEW OUTLOOK: THE PATIENT CENTRICITY
In the last twenty years all over the western world there have been enormous
changes in the timing of hospitalization of the sick. Also the pharmaceutical industry is in
turmoil, undergoing an unprecedented transformation due to a number of important
changes in its environment. All that has changed the face of labor within the hospitals,
there has been a process of rationalization that led to an important cost-containment of
health personnel for better organization of technology and most modern hotel facilities.
Authorities around the world have stepped up pressure to contain the growth of health
care costs. They limit and require the use of new and expensive drugs. Public and private
payers encourage greater use of generic drugs and a more rational use of drugs through
various restrictive guidelines. Patients are always exhorted to be more cost-conscious.
The increasing knowledge, technology, computerization, advances in medical therapy and
surgical treatment, but also the desire of taxpayers to shift some of the costs and
responsibility toward them, have meant that today patients are having an increasing
share in their own health management decisions. As the provision of health care is
getting closer and closer to them, patients can no longer be seen as passive recipients of
health care services and products.
Patients and their associations are gaining considerable power in health care
management. They want to exercise this power and, in fact, do not exercise extensively.
Patients are demanding better results that are relevant for them. Want solutions to
health, not only drugs from pharmaceutical manufacturers.
Patients expect more adherence and compliance support for complex and chronic
treatments. They are also turning towards prevention and lifestyle changes to combat
disease.
"People have the right and duty to participate individually and collectively in the planning
and implementation of health care they need."
(OMS. Declaration of Alma-Ata - International Conference of Primary Healthcare, 1978).
The centrality of the patient in the processes of care and treatment, with particular focus
to its subjectivity, his desire to know the disease from which he suffers and treatment
options available to counter it, as well as its autonomy and participation in the
management of the therapeutic path are part of a right, enshrined, moreover, by the
same World Health Organization (WHO).
In addition to ethical reasons, patient centricity is also necessary because a conscious
choice facilitates adherence to courses of treatment and prevention improving the results
in terms of objectives for public health and welfare (Malvi C, 2011).
Ethics and professional training, education and respect are the foundation of any human
relationship marked by professionalism, friendliness and politeness.
A doctor-patient relationship guided by the recognition of the increased centrality of the
patient is, therefore, imperative to build a therapeutic alliance and can also reduce the
abandonment or non-adherence to the prescribed treatment.
Clinical indications of the physician are based on scientific knowledge, but an effective
communication with the patient requires his cooperation in order to make the information
understandable, acceptable and workable in everyday life (Mechi MT. L'influsso sulla
qualità delle cure. Salute e Territorio, n. 176/2009).
The traditional view is that the " patient-centered " approach means that the patient is at
the center of a hub of service delivery, but the energy and the decision-making process
still rely on the expertise of " elect ", otherwise the patient, even if the center of
everyone's attention, it is still rather passive.
The best view for the " patient-centered " approach is that of a more powerful, active and
participatory patient. This implies that patients have access to their data-on-demand, at
will. It also implies a more collaborative and participative interaction between patients
and health care providers (physician, the medical team home, hospital, etc.) For doctors,
it implies a change in the role of the physician: learning to be not only the source of
skills, but also a support, who can help interpret the overwhelming information available,
putting it in context and also coordinate and shepherd the patient interacting with the
entire ecosystem of health care. A patient looks forward to create a real relationships
with his doctor, before and after the treatment decision, to help him better digest
diagnosis, dictate the selection of a treatment that suits his needs and lifestyle, and deal
with the ups and downs related to his illness.
The human person must be placed well in the center of the design and renovation of
hospital facilities. A suitable environment enables healthcare providers to better
conditions for their service. Decent reception favors a peaceful stay of the patient.
Facilities and services require careful management and a strict and permanent
commitment to adapting to new demands and new perspectives. Wise foresight and
courageous entrepreneurship measure the effort of a careful planning to the future
without neglecting the needs of today, grounding on the real expectations of the patient.
The first steps in this ground-shift is the provision of information to patients on-demand
that includes giving patients clinical summaries of each visit, making the electronic
summary information readily available and provide health education resources patient-
specific for each patient. Much of this can be accomplished by providing a patient portal
for viewing information collected from medical, laboratory, etc. Although quite passive, it
still is a first step.
A next step is using these portals to facilitate the interaction between patients and their
doctors. This comprises email-like secure messaging, auto-creation of events and similar
activities that replace the calls to the office. Even e-visits tune in here: an experimental
concept tried with Tele-medicine purposes, where non-emergent messages based on
structured questionnaires from patients can lead to medical decisions.
Patient empowerment, patient - centrality and the consequent need for coordinated
health care is an irreversible change of course in front of health care. The technology will
be a spine that is intended to facilitate (and even lead) the change.
The Management Centre Europe (MCE), the largest provider of talent development
programs for international companies throughout Europe, Russia and the Middle East,
conducted a survey among biopharmaceutical managers and executives during mid-
2011. 87% of the 208 respondents, representing 47 bio-pharmaceutical companies,
confirmed that their top management had declared patient centricity “strategic”.
Respondents also recognized almost unanimously (98%) that patient-centricity was
critically important or important for the success of their company.
The future of health care and the pharmaceutical industry is being driven by three main
imperatives: accessibility, prevention and patient centricity.
Patient-centricity can be defined as the application of patient insights in all aspects of
business to drive strategic decisions and tactical actions. Patient-centricity can play an
important role in every step of the life-cycle of a pharmaceutical intervention; from
product design to clinical demonstration and approval, from diagnosis to treatment
initiation, monitoring and adherence. In order to be able to implement patient-centricity
in business daily life, pharmaceutical companies have to adopt the proper mindset and
cultural changes, new tools of analysis, specific skills and experience in dealing with
patients, because patient-centricity goes far beyond promoting drugs to patients. A big
pharma industry that wants to transform its self from an industry that sells products to
one that provide services, should also undertake to:
• Better educate patients and help them take control of their disease, treatment, and
lifestyle.
• Embracing indirect interactions to patients through other interested parties such as
healthcare providers or pharmacies, providing them with the tools needed to understand
the experience of the patient and a positive impact of it.
• Engage with patients' care givers, such as families, friends and healthcare
stakeholders, recognizing their fundamental role along the recovery path.
4.3 PATIENT ASSOCIATIONS
4.3.1 Who Are The Patient Groups?
Patient groups are a form of voluntary association between people with a "specific
" illness or their family members. Their general purpose is "to fight" a specific disease
and to constitute a reference point to help all people afflicted by disease. Often, within
these associations, there are people who, although not physicians, have acquired a great
level of expertise about the pathology in question that allows establishing collaborative
relationships with hospital units, public institutions and pharmaceutical companies.
The ability of these groups to mobilize and influence health policies and research depends
on the kind of disease (if the disease has a higher distribution incidence) and also on
symbolic aspect. AIDS and cancer are examples of diseases for which there was a
collective mobilization that has influenced also on the programs of public assistance and
prevention, as well as on the allocation of resources for scientific research. Disorders less
common, even if no less debilitating or lethal, exhibit apparently minor influence (it is the
case of rare diseases).
4.3.2 What Do The Patient Groups Do?
All the activities performed by patient organizations can be listed as follows:
• collection, processing, production, distribution of medical information about healthcare
to disease, on centers of reference for the diagnosis or treatment, the problems related
to the quality of life of patients and on the aids available;
• organization of meeting between doctors and patients and services advice by telephone
or Internet, activation of counselor’s office, promotion of groups of mutual-help,
organization of regular meetings of comparison about the disease among the members,
as well as other forms of social support;
• advocacy, assistance and legal protection of individual associates, initiatives of
information and solicitation to public institutions and health services ;
• mobilization actions, protest, organization of campaigns for the recognition of rights
and the improvement of care;
• organization of information campaigns (oriented to citizenship) and to raise awareness
about the disease, organization of prevention campaigns and health education;
• promotion and support of biomedical research, collection funds for scientific research;
• organization of conferences and refresher courses for doctors and other health
professionals;
• collaboration with clinical centers for the realization of research study, clinical trials and
recruitment of participants;
• collaboration with health centers for improving life conditions of the hospitalized
patients (animation initiatives, etc.), the comfort in the hospital (purchase of furniture,
etc.), for the purchase of diagnostic equipment.
The profile of the activities of each association derives from a mix of these and other
activities. The extension of the activities is, however, undoubtedly tied to the availability
of economic and human resources. Let us now examine in more detail some of the
activities listed above.
One of the principal activity concerns the production and the distribution of medical and
health information: about the disease, diagnosis and treatment centers or different
aspects for a better management of the disease.
The information channels used are very different and each association. The most
common solutions are the brochures. In some cases, real books on the disease and its
management are realized, often in the form of "manual" for the patients or their families.
This informational material is made using today new media: DVD and interactive guides,
associative newspaper or newsletters.
Besides the production and distribution of educational material, on paper or other type,
the informative activity is also expressed in the organization of meetings with experts,
conferences and seminars, which involve patients and caregivers. The aims of these
meetings are to show research outcomes, etiologic mechanisms of the disease; to make
individual assessments of patients involved; to present and discuss treatment protocols
and rehabilitation.
The better-organized patient groups offer, including the information services, special
phone services such as free telephone lines (with operators able to provide information
about the disease and association services, legal information, etc.) or, more rarely,
information services and advice online.
The campaigns of awareness of citizenship are particularly popular; often culminating in
"Celebration" of a day or a week dedicated to the disease, frequently focus on the
importance of prevention.
Generally, the aim of mobilization is to inform and sensitize the citizens and these
events are also important opportunities for collecting founds, whose significant part is
used to promote scientific research. Many patient groups contribute, in fact, in the
financial biomedical research, obviously proportionally to their ability to raise funds.
Smaller associations often support through grants or contracts for research at the
medical centers (also abroad) with an investment of tens of thousands of Euros; larger
organizations, instead, can invest in resources for several million Euros per year,
contributing very significantly to the biomedical research about the referential pathology.
4.3.3 How Do Patient Groups Communicate With Citizens: The Web Power
As organizations and healthcare companies, scientific societies and pharmaceutical
companies, even patient associations use the web as the main tool to convey
themselves, in fact, the most of them have a website where they present the association,
provide clinical information, collect patients histories, update on new scientific research.
The use of Internet to look for health information and services is growing: this increase,
shows that the World Wide Web has become an important source of medical and
scientific information, not only for health professionals, but also for patients, who are
turning to Internet to improve understanding of the symptoms, the conditions or
therapeutic treatments.
According to some statistics, among the patients affected with a chronic disease, the 46
% claim to have improved the understanding of the possible treatments and 27% had
improved their ability to manage their disease through web research of information.
On the other hand, this increase shows the presence of a health information needs that
are not satisfied by the "authorities": doctors and health services. Society is changing:
citizens on average more educated and more determined to participate in decisions about
their health or to manage their disease, so they turn to the Web as an additional source
of health information. This is even truer, reasonably, if the disease threatens the life or
can entail serious disabilities, in fact diseases such as cancer, chronic degenerative
diseases, rare diseases are the pathologies for which most patients seek information. The
research conducted on patients with cancer, for example, shows that most want to get as
much information as possible about the pathology, treatment options and side effects
(Jones et al. 1999 Leydon et al., 2000). In additional, the percentage of dissatisfied
appeared higher among those patients treated by more time, because as the "career" of
the sick advances (so his expertise advances), the patient gets more aware of
incompleteness of the information received. Hence, the need of looking for the health
information in an autonomous way is growing.
Patients using Internet, both chronic sick and sick neo-diagnosed, therefore, are not
interested in general care information, but targeted to explore a specific disease, health
services better equipped for the diagnosis and treatment of the disease. The need to
acquire “focused” information is perfectly in line with the offering of information and
services implemented by patient organizations through their websites. Of course, the
sites of the associations are only a small part of clinical information now present in the
web. There are also information sites or web pages on the topic prepared by scientific
societies, research teams or individual professional, publishing companies in medical
field, medical institutions and pharmaceutical companies, as well as medical and scientific
journal available online.
According with the specialization of associations, even the websites are focused on
specific pathology. This allows getting information on the disease and on the topics
associated with it. Like so many health information sites provide information about the
medicine on the whole or subsets of disciplines (cardiology, psychiatry, etc.) that is, they
give "horizontal" information (great thematic largeness but lacking depth), the sites of
patients groups are, according to the very nature of promoting associations, strongly
focused, that is, they give "vertical" information (narrow topic, but a great in-depth
analysis). In such sites, if well organized, you have the chances of finding information
relevant to all people affected by specific referential pathology. Therefore, the
collaboration with clinicians and researchers (several associations have also a Scientific
and Technical Committee) ensures that medical information found on these sites has
good quality.
Patient groups also offer knowledge and skills that integrate knowledge and skills of
health professionals or, more generally, the health services. Even these competences are
made available through the association’s websites. The information is about two complex
themes. First, because the groups involve people who have direct experience with the
disease, they are able to show that special “know-how” that comes from this experience,
so we often use the metaphor of "journey" - the patient journey (Lapsley and Groves
2004 Baker and Graham 2004). This means, that the sites provide information not
delimited to the diagnostic or therapeutic time, but, for example, extended to the
preparation of the meeting with the doctor (through the realization of a "memo" to not
overlook important aspects in the clinical interview); the identification of specialists or
centers of reference for the disease (many sites have a lot of information compared to
health services, and this highlights a need for information that still does not find an
adequate institutional response); the rehabilitation, the self-management disease
(extremely important for chronic conditions), up to the social reintegration. Secondly, the
associative expertise facilitates the preparation of information and services, which are
also delivered via web, which is not only the medical aspects in the strict meaning, but
rather include all aspects that concern the quality of life of patients: the acceptance of
the new conditions, information on the prosthesis and on assistive technology, inclusive
education of children with serious illnesses, the impact of the disease on family life,
sexual activity in the new situation and so on.
Another aspect is related to the information aimed to realize opportunities for social
support. The exchange of information and the comparison of experiences among informal
patient groups, who meet periodically, also create social relationships, attachment and
willingness to help. These groups of "equal" realize a peculiar bind between information
exchange and social support that various associations propose through "virtual" as
interactive forums or newsgroups. The association provides two resources base for the
good operation of the forums: its expertise and a group of "activists" of the network, to
support a sufficient number of communication exchanges for guarantee the viability of
the forum. Supported by this structure, the forums allow circulating both information and
emotional and social support, expanding in this way the range of the traditional groups of
mutual aid. It is well to remember that are theoretical opportunities.
In fact, the real opportunities used by patient organizations through their websites,
actually depends on several factors: including the availability of economic resources, the
propensity for innovation and participation in networks that make innovation possible,
the level of expertise in usage of Internet for associative purposes and the measure of
organizational commitment in the management of the site. In this regard, it is essential
to remember the importance of economic resources that each association is able to
invest in the construction and, then, in the maintenance of the website, although there
are several examples of small groups using more advanced websites in terms of the
wealth of information and services offered, compared to associations dimensionally
larger. In some cases, indeed, the websites with a considerable number of information
are the result of individual initiative, often of patients or parents of sick children. Some of
the sites are composed of a few static pages (with only some essential information about
the association), while others show a greater wealth of information, a better quality of
graphics, effective organization of information, the presence of advanced information and
interactive services.
4.3.4 The Role Of Patient Groups In Italy
In Italy, unlike what happened in other Western countries, the world of patient
groups has received little attention so far by the side of social scientists, despite this
event is more and more present and visible in the modern society. In the last decade,
this event strongly increased in our country and many hundreds of patient organizations
are operating today. In addition, many information and awareness campaigns about
health and illness and many initiatives for raising funds for biomedical research are
promoted by such associations. This justifies the visibility of the associations on the
press, in the Italian squares, alongside of the professional health figures in many hospital
or outpatient centers.
This is an issue that involves the entire Western Europe, although the level of
development, the dominant organization philosophies, the measure of involvement in the
public health policies or the ability to exercise influence on public and private research
change from country to country. In any case, although later compared to Anglo-Saxon
World, patient associations have now become a negligible reality in the Italian health
overview.
The context in which patient associations are operating has changed and is constantly
evolving, coherently with the transformation patient’s role in the present society. At the
beginning, there was a “paternalist” model, based on a “simply” voluntary activity,
implementing or replacing the work of the Health Service. The associations, therefore,
were mouthpiece for the needs of the patients, with a meaning rather “passive”. Now it is
replaced by a “participatory” model as a natural consequence of the revolution in the
doctor-patients-citizens-National health service relationship.
The scenario of patient groups is particularly heterogeneous. They differ in: type of
organizational structure, continuity of contact with the public and type of services offered
to patients/citizens, training of volunteers, lobbying at the political level and knowledge
of the research themes and topics that are related to.
The Italian associations, then, follow two line of activity:
- one internal: shooting for support, assistance, advice, information and other services
for members (“service”);
- one external: shooting for influence, dissemination and information to citizens,
institutions, organizations, politics, activities (“lobby”);
The service was first developed historically and is common to all patient groups, with
some differences in extent and quality, the lobby is quickly growing only in the last few
years, up to become the predominant activity (sometimes also the main source of
funding) for many associations, because some of them want to expand the range and get
benefits for their members, but also because lobbying is perceived as a powerful tool
conditioning economically significant decisions.
With the development of the centrality of the patient, the disease is not more considerer
as a set of parameters to be reported in order, forgetting to measure, even in a scientific
manner, the quality of life and priorities of patients. It is essential that patients organize
themselves as active subjects and not just as objects of study. In the U.S. and in Anglo-
Saxon world, where the habit to act on interest of the groups and associations is more
entrenched, this allows the development of patient advocacy, a mode of participation of
patients in everything related to their disease, from the research to the choice of
therapies, through the personal commitment in support groups. Now this model is
making its way to Italy.
The strategic importance of the role of associations, that can shift demand in the health
field and create movements of opinion, begins now to understand by the association own
federations themselves and so by the patients. Pharmaceutical and healthcare managers
at various levels recognize in them a privileged and precious resource, with benefits that
will be better examined in subsequent chapters.
4.4 PATIENT ASSOCIATIONS AND PHARMACEUTICAL INDUSTRIES: THE
GUIDELINES
Patient associations represent important partners for pharmaceutical companies.
They share the interest to make sure that patients can understand and better manage
their disease, promptly and equitably access to better treatment they need and establish
a dialogue increasingly aware with their doctor.
It should be emphasized that patient associations can help pharmaceutical companies to
understand what it means to live with a disease and what are the needs of patients; for
publicity purposes ("Corporate Social Responsibility"); influence and inform patients
about drugs not promulgated to the public and, indirectly, the regulatory agencies for
approval of drugs; define the role of drug therapy in the management of the disease;
provide the company with more input on how to support health care providers, which in
turn support the patients. On its part, the pharmaceutical company is able to: offer
professionalism, experience and knowledge to support the activities of patient
organizations; possible contacts with therapeutic opinion leaders; participation at
conferences. Especially in recent years, pharmaceutical companies expressed an
exponential growth of interest in patient groups, which led to the formulation of
standards of transparency and manuals of good behavior in order to optimize the
collaboration between companies and associations. These reports, however, may be
subjects of conflicts of interest, such as the possibility of using associations to exert
political pressure in favor of specific pharmaceutical products.
For some organizations these collaborations allow to carry out their activities and
increase the sensitivity on the disease of interest; others are critical because they expose
themselves significantly to the influence of drug industries. For this reason, the
Association of British Pharmaceutical Industries (ABPI), established, in 2006 that
companies, through its website and the annual report, must explicitly declare the funds
donated to associations, indicating the amount and purpose of the loan. The Anglo-
Saxons have historically been more alert and active in the protection of civil rights,
measures of advocacy and lobby to advance the interests of patients and citizens. This is
the reason why many associations of these countries are more aware of their power and
role, and about the risks they are running in regards to the issue of conflict of interest.
Even according to the opinion of Dr. Paola Mosconi - scientist at the Laboratory for
Research of the involvement of citizens in Health, Mario Negri Institute for
Pharmaceuticals Researches - in Italy the situation is mixed: many associations are
active, sentient and move in different decision-making contexts confronting with the
pharmaceutical industry, with local or national authorities; others are more dedicated to
the activities of care and support, and less attentive to issues of lobby and advocacy.
Therefore, in general, the issue of conflict of interests is little heard, and not considered
as critical. But even in Italy, through the Code of Ethics, written by Farmindustria and
presented in October 2012, it was stated that there is a need for clarity and transparency
between the pharmaceutical companies and patient organizations:
"Pharmaceutical companies will have to make public through their official websites, for a
period of at least 3 months, coinciding with the first quarter of each year, the list of
associations of patients supported by them in the previous year, together with the
underlying purpose of such support and the economic value of loans disbursed to each
association. "
From a survey conducted, by the Mario Negri Institute for Pharmaceuticals Researches,
the level of transparency of the Italian companies and Italian offices of pharmaceutical
companies is lower than that of companies abroad, in terms of completeness and
accessibility of information about the sponsoring associations of patients. Although the
policy on transparency with regard to sponsorship of associations may vary according to
the location of the pharmaceutical company, in accordance with the legislation of the
country and the codes of conduct of national or international groups to which companies
belong, there are certainly risks associated to the lack of transparency. First, there is a
general loss of credibility of the funding and the financed entities in the eyes of the public
and, subsequently, an increased risk of influence by the sponsor, in a non-transparent
and explicit context.
The same transparency is also required to associations, as well as indicates Simon
Williams, director at “The Patients Association”, in London:
"If a group receives money from any source, including government, must declare it. We
make it clear on our publications and on the annual report of any fund we receive. "
At the same time it is important that associations maintain their independence from the
sponsor with which it have established a partnership, although, in general, it is difficult to
uniquely define the conditions to put in place by the associations to maintain their
autonomy. And this last may be difficult to maintain, especially when the interests of the
association and the pharmaceutical company diverge.
There is a range of lines, says Dr. Cinzia Colombo, scientist at the Research Laboratory
for the Involvement of Citizens in Health, in addition to the choice not to accept funding
from pharmaceutical companies, which may be useful to limit the influence of the
sponsor and to maintain their independence of action and decision:
• Do not rely on a single sponsor, or by a single type of sponsor
• Accept only unconditional loans: get finance for a project already defined, or packages
of interventions or of projects
• Maintain independence of information and divulgation on activities and results of the
projects
• Increase the moments of self-paced training, exchange of information, swelled
awareness
• Making public on web donations, funding by pharmaceutical companies (as a % of
budget), funded activities, balance sheet
• Draw up codes of ethics, guidelines, maybe comparing with other associations, to find
common ways and together to cope with the potential problems of relationships with
sponsors
• Network with other associations to increase their voting power
• Point to transparency: requiring that the results of clinical trials and clinical trial data
are made public
Thus, they have been identified guidelines which establish the principles on which should
be based a relationship between a pharmaceutical company and any association of
patients, a "code of conduct" also drawn by the EFPIA, the European Federation of
Pharmaceutical Industries and Associations.
Among the principles that the guidelines invite to observe are:
INTEGRITY:
• any activity undertaken in conjunction with a group of patients should encourage the
latter and be included under the statute of the association;
• the pharmaceutical company will not try to get information from the associations about
competitors, or to acquire other confidential information;
• industries and associations must find a way to eliminate any perception that one party
has influenced so unjust or unfair the other party;
INDEPENDENCE:
• the independence of patient organizations must not be compromised, nor should have
the feeling that it is, as a result of the collaboration with the pharmaceutical company;
• associations of patients will not be asked to support any specific pharmaceutical
product;
RESPECT:
• pharmaceutical companies and patient organizations will have to respect the goals,
objectives, priorities and ways of working of each one;
• it is appropriate to enter in a written contractual agreement for all joint projects, which
will include some or all of the following elements: purpose of the collaboration;
contribution of each party; outcomes and deadlines expected; confidentiality, where
appropriate; responsibilities of each party involved in the collaboration; how both parties
intend to keep in touch with regard to collaboration, how and in what circumstances will
be placed end the business relationship and as such interruption will be communicated;
what will happen to any loans granted if the project is not carried out or forward; how
you should advertise collaboration;
EQUITY:
• both sides of the collaboration relationship must be considered equal;
• any benefit, financial or of a different kind, offered an association will be appropriated
to the its size and its organizational capabilities;
TRASPARENCY:
• the pharmaceutical company will try to establish with the patient organizations clear
and transparent collaborative relationships to each other;
• any partnership must conform to the requirements of law, regulatory or ethics,
applicable to the pharmaceutical and / or the association of patients;
• the pharmaceutical company reported on its website a list of all the associations which
provides significant support, indicating the amount and purpose.
It must be said that there are organizations of patients that do not accept funding or
other support from pharmaceutical companies, because they feel that this would not
allow them to be autonomous and could undermine their credibility with respect to the
role of protecting the health of all people they represent. Those associations that instead
accept loans or other forms of support, consider that - in the face of very little money
available, and a few public money - this is a source to be able to carry on its business,
where the pharmaceutical industries are an interlocutor with whom to collaborate for
common goals.
5 FIELD RESEARCH: OUR INVESTIGATION
5.1 EMPOWERMENT ACTIONS
Empowerment may be a social, cultural, psychological or political process through
which individuals and social groups are able to express their needs, present their
concerns, devise strategies for involvement in decision-making, and achieve political,
social and cultural action to meet those needs.
Confining the definition in the health field, empowerment is a process in health
promotion through which people gain greater control over decisions and actions affecting
their health. Health promotion not only encompasses actions directed at strengthening
the basic life skills and capacities of individuals, but also at influencing underlying social
and economic conditions and physical environments which impact upon health. In this
sense, health promotion aims at creating the conditions, which offer a better chance of
there being a relationship between the efforts of individuals and groups, and subsequent
health outcomes.
In a society and a health care focusing increasingly on patient centricity, through the
sharing of treatment paths, empowerment plays an important and encouraging role, both
for health professionals and for the community. It is a strategy: through health education
and promotion of behavior conducive to health, empowerment provides people with the
tools to make the best decisions for their welfare, reducing the cultural and social
inequalities. It is therefore a sort of "information therapy", which aims to reduce the
asymmetry of knowledge between the physician and the patient, but also to reduce
unrealistic expectations that reflect in a growing consumption of health services.
The patient "involved" gets better results with lower costs.
This event is a clear consequence of the actual health contest: the world of medicine has
transitioned to a system that takes control away from both patients and their doctors,
giving rise to a new paradigm that requires patients to take more responsibility for their
medical care than in the past.
Patient empowerment has a handful of definitions. Most focus on the concept of the
patient taking an active role in his own disease management, and supporting that
participation by learning all he can about his disease or condition and treatment options.
Until the past few years, the thought that a patient would participate so fully was
unheard of. Today, many patients realize that this level of participation is vital to
maintaining health in the face of medical problems or challenges.
As an empowered patient, you'll need to:
Take responsibility. Realizing that you know your body better than anyone else, you will
refer to all the resources at your disposal, from people to the printed word, and you will
use that knowledge to help make decisions about your treatment that are your decisions
to make.
Set goals. Understanding that the human body does not always react the way we expect
it to; therefore, it is best to set a treatment goal and work toward that goal. In some
cases, a patient can have a goal to heal, another may simply want to manage a disease
or condition, or another may need to learn to cope with a new medical problem.
Collaborate with others. You'll be an active participant on your own healthcare team,
including providers, support personnel, payers, even other patients, knowing that the
collaboration helps you in the decision-making aspects of your diagnosis and treatment
processes.
Gather evidence. Including resources that range from observation, to recording
symptoms and family histories, to participating in medical tests, to discussions with
providers and other patients, to using the Internet and libraries for researching relevant
diseases, conditions and treatments.
Be a smart healthcare consumer. Sometimes the challenges that a patient faces are
related more to customer service and costs of service than they are to the health aspects
of care. Understanding health insurance choices or learning when to walk away from a
doctor's practice when necessary, are examples of these kinds of choices.
Stay safe in the healthcare environment. We often read about major medical errors, but
millions of "smaller" mistakes take place every day. Administration of the wrong drugs,
acquiring infections in hospitals, even surgeries gone badly, these are all examples of the
safety problems an empowered patient should be aware of.
Understand and support the tenets of patient advocacy. In the big picture, you can take
advantage of those who have learned about your medical problems before you, and you
can help patients who come after you find better medical outcomes. Advocacy runs the
gamut from government and not-for profit organizations, to individual navigators that
help patient’s transition through the steps of their diagnosis and care.
Adhere to decisions. Since you will have collaborated with knowledgeable members of
your healthcare team to arrive at decisions, you will feel confident following along with
the decisions you have made together.
So, promote Empowerment does not mean giving power to whom do not, but encourage
the full development of the skills and resources that are present in individuals, groups
and organizations.
5.1.1 Patient Advocacy: “The Voice Of Who Did Not Have The Voice”
This word has its origin in the legal field and generally defines the set of modalities to
representing someone. This concept has changed over time thanks to the activities of the
civil society and associations in defense of the rights of the sick. In the health field,
considering the disadvantaged social, geographical conditions, even for the impact of the
disease, the concept of “advocacy” has been simplified through the slogan: “The voice of
who did not have the voice”. In more detail, the term advocacy is defined as “the
strategic use of information and other resources (economic, political, etc) to change
political decisions and individual and collective behaviors in order to improving the
individual or community health.
Practicing advocacy presupposes the activation of a series initiatives focused towards the
demand of initiating a process of change. And the changes can be either related to
policies, laws, but also related to awareness for the subject at hand or the observance of
the recognized rights.
In its simplest terms, patient advocacy regards any activity that ultimately benefits a
patient. Using that definition, it can apply to care giving for an individual patient, to
groups that develop policies and advice that help patients, to government groups that
develop legislation to improve systems or processes for patients.
In our survey, we have interviewed Stefania Vallone, secretary of WALCE (Women
Against Lung Cancer in Europe – Onlus). Founded in 2006 by Dr. Silvia Novello, president
of the association, aims at raise awareness among women on the rise in the incidence of
cases of lung cancer mortality in the female sex. The association seeks to create tools in
support of patients but also of all those who are involved in this "journey", from
diagnosis to treatment and any side effects due to treatment.
Is it important for you to establish partnerships with the pharmaceutical
companies? Why?
Yes, our association has done it from the beginning. Much of the financial support comes
from their own. Thanks to them, we are able to accomplish many projects, which have
considerable costs for their realization. This support especially concerns the information,
through the production of brochure. The pharmaceutical companies collaborating with us
are LILLY, PFIZER, ASTRAZENECA and ROCHE.
In addition to the economic advantages, we can mention others: very often the
pharmaceutical companies organize meetings in which invite patient associations. In
these occasions, they introduce a new drug to ask us feedback on the topic of
communication, in relation its promotion, for example, about the realization of a kit that
accompanies a drug. So the advantage is to know even before the drug is launched in
the market, all communication that is around it and to have a voice in the matter. We
are, therefore, absolutely protagonists with them in dealing with all that direct
communication with patients.
How do you manage to maintain an independence of thought despite
partnerships with pharmaceutical companies?
Through the creation of partnership with more pharmaceutical companies and not with
only one. Therefore, very often projects are co-sponsorships and, in any case, we are the
authors of the project that we propose to the pharmaceutical companies.
What are the difficulties found in the relationship with pharmaceutical
companies?
Regarding Italy, there is a lot of bureaucracy, and then when we decide to receive a gift,
we have to do several steps, wait for some time. It is the same bureaucracy that we
meet with national institutions.
Which tools (if there are any) do pharmaceutical companies use to understand
the "unmet needs" of patients?
I think they are useful, primarily, because without their support, the most projects would
not be realized. The main purpose of these is not the rehabilitation of the patient because
the prognosis is very limited in time, but the improving the quality of life of the patient
during the period of treatment, usually not larger than one year as this is the prognosis
for lung cancer. So thanks to them, for many patient groups as small as ours, it is
possible to accomplish things that we could not otherwise do, and this allows us to help
thousands of patients scattered throughout the Italian territory.
In which way could companies improve the use of these tools?
In the relationship with the pharmaceutical companies would be advantageous to have a
unique point of contact for creating a kind of loyalty with the person in order to get a
faster implementation of projects and to have greater attention to what is being
proposed. In fact, pharmaceutical companies have a considerable turnover and not
always people are already experienced in this type of subject, and also not in every case
there is a section devoted to patient advocacy, the development of a team of people that
deal exclusively with the needs of patients through the relationship with advocacy is a
fairly recent event. The patient appreciate that the pharmaceutical industries, in addition
to the production of the drug for their therapy, employ some funds to meet their needs.
And this has a positive effect on the image of the companies.
What relationships do you have, if you have any, with government policy
makers?
We had mostly relations with the Regional health, not great contacts at the national
level. Since 2010, we and other associations asked for the patients who are in cancer
treatment and then lose their hair, if it was possible to buy a wig and get a refund
region. Fortunately, we are one of the few Regions in Italy to enjoy this right: it is 250
Euros, which are not many, but for many people who already have other costs, are a
little aid. So in general we turn to policy makers/institutions on practical issues, projects,
organizations and events, information and communication, because to have a support by
the side of who play a certain role in healthcare gives another value to the presentation
of certain programs, corroborating the importance.
Could you tell us a successful experience in the field of patient advocacy?
Three recent experiences:
• A photographic exhibition that involved 3 of our patients with 20 pictures that were
trying to depict the daily lives of themselves. They tried to give an idea of "normality" of
the life of a sick person. An initiative started by our hospital and later became a traveling
tour and finally shows who turned 17 Italian oncology departments, to arrive finally to
America in one of the most important Patient advocacy structure in America. This
initiative was supported by Astrazeneca;
Picure 6 – Daniela and her daughter Valentina together. There is a lot of love and complicity between them. "At the
beginning, my daughter was more scared of me: he was 18 and told friends that her mother had bronchitis." Valentina is
now able to live better with the disease of the mother and Daniela finds in her daughter the strength to fight the disease.
Impossibile trovare nel file la parte immagine con ID relazione rId14.
Picture 7 - The chandelier in the Denis home's dining room seems to blend with the clouds of the sky. “I do not care to
know the name of my tumor, neither the name of the drugs that I have to take. I do not even want to know how they
act on my body. I just have to give my best to face life, every day. I have to live a normal life, to be present for me and
transmit the same to others.
Impossibile v isualizzare l'immagine. La memoria del computer potrebbe essere insufficiente per aprire l'immagine oppure l'immagine potrebbe essere danneggiata. Riavviare il computer e aprire di nuovo il file. Se v iene v isualizzata di nuovo la x rossa, potrebbe essere necessario eliminare l'immagine e inserirla di nuovo.
Figura 8 - A passer-by at the home of Barbara. "It may seem like a paradox, but the disease helps to enrich
relationships. I did not want people to feel pity: one thing that makes me meditate and sadden the most, is that, my
social status is changed from that of a healthy person to the one of a sick person ".
*
• Another important initiative is "How to feel better with make-up" that consists in an
itinerant make up lab, that travels in various oncology Italian and Spanish hospital
wards. The project was supported by Roche, Pfizer, AstraZeneca and Celgene .
Figura 9 - The poster of the event in Peyrano
• And then, a very recent proposal that we presented in November 2013 that is an
educational, but at the same time motivational video about smoking. For the first time
we were able to involve some "important" people and VIP, because the problem of this
pathology is that there is not a media attention around it as is the case with other
illnesses. The intent is to get it in the national circuit. The initiative was supported by
Roche.
5.1.2 Pfizer And The Encourage Of “Viverla Tutta”
"Viverla Tutta" is a communication and social campaign, sponsored by Pfizer, with the
involvement of the Scientific Community and Institutions. It promotes the development
of tools, methodologies and initiatives aimed at promoting the centrality of the patient in
medicine and health, and at building concrete answers to improve the paths of diagnosis,
care and treatment according to the actual needs. The protagonists of the campaign are
the patients and the caregivers with their illness stories, which are collected, interpreted
and measured by specialists of Narrative Based Medicine (NBM).
NBM, born in Anglo-Saxon countries and widespread in Italy in the later years, focuses
on the therapeutic role of the illness story told by patient and on the sharing of the
experience. Narrative, therefore, has a twofold value: on the one hand, it helps the
patient to neaten his life up, to give a sense to the experiences, to position them at the
space-time level, becoming therapeutic; on the other hand to helps the doctor to know
the person in front of him, to build shared care pathways, to improve compliance.
Pfizer used this initiative to offer an alternative reading of the disease as opposed to the
prevailing social mindset that considers it as a negative event. The individual history of
disease provides a valuable opportunity to redefine the traumatic experience for the
patient and help him to rebuild the new identity that derives from it. The patients’ and
caregivers’ stories can help to understand the subjective perception and interpretation of
the disease and the way to deal with it.
This project has several purposes: understand the health needs of the Italians, the
expectations, the level of satisfaction and the areas for improvement; put the patient at
the center of the care pathway, promoting the sharing and exchange of experiences and
feelings; increase the spread of NBM paths to improve diagnosis, care and treatment and
to disclose the “unmet needs” which remain often dissatisfied.
The point of departure for the project was a social survey conducted by GfK Eurisko,
titled "The Italians and the courage to Viverla Tutta", which aims to investigate the needs
in the health field and, in particular, the value and importance of listening and sharing for
people affected by disease. The results were very significant:
Picture 10 - Homepage of the website “Viverla tutta”
The patient is in the support of the patient centricity:
Over 80% of the interviewed consider that is very important put the patient in the center
of the treatments
Picture 11
- Approximately one interviewed on two, considers that we can emancipate the patient
further:
Picture 12
The importance of the doctor role
Despite the presence of a scenario of great uncertainty, the figure of the doctor - and in
particular
the basic one - is confirmed as an important reference point:
The 65% of the interviewed declare to appeal a basic doctor
Picture 13
And, in the management of the disease, approximately one third of patients and
caregivers recognize feeling much or very much supported by both the family doctor and
the specialist, while the support from the Health Care System, the patient organizations
and people who share the same disease, is still modest.
Picture 14
The importance of telling and sharing the experience of the disease:
Approximately 86% of all interviewed recognized the importance of the story and the
sharing with the other
Picture 15
In particular, more than 30% of patients and caregivers surveyed think that the
opportunity to tell their own personal experience with the disease and compare to others
can help to:
- overcome moments of distress
- accept the situation and deal with it
- feel less alone
- find tips and information
- give vent to the anger
- however, find a positive way
Picture 16
Pfizer supports the first web research about NBM “Viverla Tutta”: it is a virtual and
interactive platform for the sharing of illness stories (www.viverlatutta.it). The space for
the report is free. The patient can start from the first symptoms or from the difficulties
found to get to the diagnosis, the problems associated with the treatment or the need to
change his lifestyle habits. The main goal is to tell him-self and in what way, he has
found the inner courage to "Viverla Tutta", reacting to suffering, dealing with obstacles,
fighting the battle against the disease. In the portal there is a specific space where the
visitors can leave their story, answering to a questionnaire or leaving an open story: in
this way, they can turn it into a gift of competence, rich in meaning and useful for others.
Alongside each story, you can leave a comment, or express solidarity or closeness or
exchange information and opinions, compare experiences and feelings.
The second part of this initiative involved the intervention of experts who interpreted
these stories, according to the techniques of NBM and following a protocol realized by
Scientific Committee. They integrated the stories in the context of a larger study that
includes analysis of individual interviews, conducted by doctors of ASL 3 of Florence in
the field of the NaMe Project. The aim is elaborating, by 2013, the guidelines to promote
integration between the Narrative Based Medicine and Evidence Based Medicine, in the
field of rare and chronic diseases in our country.
The first edition, launched in 2011-12, in collaboration with Repubblica.it, achieved
significant outcomes: in the period September 2011 – March 2012, over 1000 stories and
more of 4000 answers to the questionnaire were collected on the web. The success of the
campaign testifies a great desire to share the experiences of the patient and caregivers:
people, invited to summarize their history, burst the taboo of privacy and write their
statements. The research has already arrived at a multitude of Italians who wanted to
donate their history of illness and care to others, even if unknown.
The campaign obtained the participation of the whole company: the staff was
continuously informed about the progress of the project through the tools of internal
communication (intranet, weekly Newsletters, posters and interior monitors, etc.); 40
employees also took part in the training seminar organized by Pfizer Italy on the NBM.
Another 100 people of the company also participated in two meetings for the
presentation of the activities of Kids Kicking Cancer, an American association committed
to help children with cancer to overcome stress and fear with the use of martial arts. In
addition, to supporting the Association at the international level, Pfizer Italy decided to
give its support in the campaign “Viverla Tutta” during the inauguration of the Italian
branch of the Association (Kids Kicking Cancer Onlus Italy) and in the first master plan in
Italy, in collaboration with Children's Hospital Bambino Gesù. Some employees of Pfizer
became volunteers of the Association and were been trained for this purpose.
5.2 THE POINT OF VIEW OF PHARMACEUTICAL COMPANIES: OUR INTEVIEWS
Given that the trend of recent years shows a more central role of the patient and an
increasing interest in patient groups, we involved some Pharmaceutical Companies to
better understand how these issues have impacted and influenced the Pharmaceutical
world.
Novartis Pharma has been among the first companies to believe strongly in the role of
the patient in treatment decisions and to recognize the value of patient organizations
towards the institutions, as spokesperson of sick people. This, from 2008, has entailed
the creation of the first capacity-building project aimed at patient associations, called
“Alleati per la Salute”, becoming the pioneer company incorporating the views of patient
within their own institutional strategies.
Pfizer also was among the first companies to believe in the growth of influence of patient
associations and to establish a stable and structured relationship with these realities.
Already for several years, in fact, exists a professional figure dedicated to the
relationship with patient associations, and from 2011 has been launched “Viverla Tutta”,
an interactive platform to talk about themselves and the experience of illness.
For Bayer HealthCare Pharmaceuticals, patient has always had a central role. In recent
years, sick people have been more considered in their human nature, to give them voice
and especially listening, and then recognize that Pharmaceutical Companies cannot refer
only to Key Opinion Leaders (KOLs) in their action plans, but they must have greater
sensitivity and support to the expectations and needs of the patients.
Biotest Pharmaceuticals Corporation is directing more and more its attention to patients,
well-aware of how much patients can influence the physician in the choice of treatment
to follow. An effective example of this approach is Zutessa, a contest brand that offers
services to transplanted people to improve the management, treatment and
hospitalization, focusing on adherence to therapy, not only in behalf of patients, but also
physicians, supporting and facilitating their work.
Generally, all Pharma Companies tend to work with the associations within the
therapeutic areas in which they are involved.
But how do the Companies choose the associations to collaborate with? They can directly
get in touch with them by presenting their project and involving them depending on the
therapeutic area, as likewise Associations can present to companies a specific project
study, which then is evaluated by the Ethics Committee, composed of Country Head
Division, the Medical Director, Legal Office and other key figures.
It is precisely the collaboration with the patient associations that permits the companies
to be able to know their unmet medical needs. The collaborations between
pharmaceutical company and patient associations are born from the necessity of the first
to fully understand the unmet medical needs of patients and as a result, of being
subsequently able to fill them. The effectiveness of these partnerships depends on the
approach used by companies, which must be bottom up and not top down. Listening is
then the basis of such collaborations. Companies must then approach associations as a
simple listener, resisting the urge to influence the choices made by patients themselves.
In recent years the medical community is realizing the importance of having a link with
patient organizations and to conduct joint projects. On one hand this can give doctors a
wider view of the situation and on the other it can help them regain their profession,
flattened over the years by the growing bureaucracy.
One of the actions that the Pharmaceutical Companies are increasingly trying to
accomplish is to be mediators between patient associations and those of doctors, working
in the same field of therapy. The intent is to make them understand that together they
can have a greater impact on institutions and might be able to put more attention on
both the rights of those who work in health care and of whom must be taken in charge
by the health care.
One of the most important problems that are encountered in working with medical
associations is related to regulations and legal restrictions. Even the associations of
patients who have a doctor as a president have most important legal restrictions, since it
may create conflicts of interest mainly related to prescriptions. Often in these cases, just
to avoid conflicts of interest, internal company policies are more stringent than state
standards. Pfizer has long since established the guiding principles that govern relations
with the associations, based on transparency, independence, ethicality and on principles
taken from the EFPIA Code.
As explained in chapter 4.4 , there are advantages for the company in tightening
collaboration with the associations, especially by allowing the company to put the patient
at the center of their action plans and strategies. Although to a lesser extent, from the
point of view of the company, together with the advantages , there are disadvantages .
Obviously it is not possible to talk about drugs with the associations, to avoid any form of
indirect advertising. For example, Bayer HealthCare Pharmaceuticals specified us that in
case of questions or concerns about drugs, turns to the medical department, connecting
the internal contact persons with the presidents of the associations. Otherwise, Novartis
Pharmaceuticals stated that these disadvantages reside mainly in the short and medium
term. In fact, it must be considered that a patient organization has its own time, its own
language, its own identity, that inevitably slow business processes that already are
complex and problematic. In some way, disadvantages are strictly related to the concept
of participation and democracy, as to join two points of view is necessary to compromise
or slow down the processes. At a first step, this seems to be a shortcoming, but by a
more forward-looking perspective, it allows to find a partner who would not otherwise
have had.
Finally we asked what were the relations of companies with governmental Policy Makers.
Pfizer, in recent years, has created a structure totally dedicated to this, the Health
Strategy & Innovation, which has as its major counterparts all policy makers at both
national and local level. It aims to promote and communicate the company's value and
the contribution to the institutions as a partner ready to draw innovative projects with its
stakeholders, giving a benefit for the entire community of which the company is a part.
Bayer has set up regional functions, access structures that interact with the regional
authorities. In each region, being in its own right, there is a person that takes care of
those relationships with institutions. So the company can be better informed and updated
about what are the procedures to be followed in any given region, such as changes about
the recordings, prices and procedures in general.
5.3 THE PEOPLE OPINION: OUR SURVEY
In order to support our investigation at best, we have spread through the web (social
networks, e-mail, web sites related to the topic) a small survey, consisting of 11
questions. Our intention was to become aware of the actual information level about
patients association, pharmaceutical industries and their possible collaborations.
The statistical sample analyzed (320 respondents) was divided into 3 age groups and
composed largely of student population:
89 % is aged between 20 and 35 years, 7% between 35 and 50, 4% higher than 50
years.
52% of respondents is a student, 12% belongs to the category of professionals working
in Healthcare, 4% worked in pharmaceutical companies, 33% indicated as "other" their
profession.
Unfortunately, the characteristics of the sample partially spoiled our investigation, as we
referred to a narrow niche of the population. Surely, further diversifying the means of
diffusion and over a longer period, this survey could be expanded and integrated
subjecting the questionnaire to a more numerous and more varied sample.
However, willing to investigate what chronic diseases were borne on the population, we
asked respondents:
- whether or not they were in direct knowledge of cases of chronic illness such as
diabetes, cancer, cardiovascular and respiratory diseases : 87% responded yes, 13 %
no: confirming the global trend discussed above .
- focusing on patient associations, wondering if they were aware of their existence and, if
so, what in particular. 72% no and 28% yes. Of the latter, below, there is a list of the
reported associations:
Agdal, AIL, a.p.e. Onlus, AIC, NSIAs, ANT , LILIA , AISM, AGOP, FRIENDS, NGO, the
Italian Association of COPD Patients Onlus, Williams Syndrome , Chron sick Korea ,
Diabetes, Congestive Heart Parent Project, AFMA , several cancer oriented associations
as AIMaC Italian association diabetic association diabetic CnAMC Italian Association for
Cancer patients EPAC ANF or diabetes associations neurofibromatosis AISLA CESVI
diabetic Association Fatebenefratelli Hospital Association CML patients Aima AICI ( Italian
Association interstitial cystitis ) , Italian neuroblastoma Association cystic Fibrosis
foundation AIDO WALCE ANMAR AISM FAND .
As it is easy to deduce from the data, most of the associations shown are rated
organizations supporting research and a strong media impact.
The next question: " If I came to know that you suffer from a chronic illness, in addition
to the doctor, what other source of information would you use? ", Respondents replied:
35% said they intend to consult organizations of patients, 29% would consult the blog of
patients suffering from the same disease, 26% would search for information across sites
of public health and 4% to the websites of pharmaceutical companies. The remaining 7
% indicated "other " for his answer.
Picture 17
In order to study the aspect of the relationship between patient organizations and
pharmaceutical companies, given the increasing interest that these are developing
towards reality linked to chronic diseases, we asked respondents if they knew that some
groups of patients are financially supported by pharmaceutical companies. 85 % of
respondents said no, 15% yes .
Also in this area we have examined the surveyed by asking if, in their opinion, a direct
relationship between patient organizations and pharmaceutical companies could be
useful.
36% responded, "Yes, because in this way the companies can directly interpret the needs
of the patient";
33% responded, " Yes, because a direct relationship could provide financial support for
the implementation of projects and initiatives in support of the patient";
The 23 % " No, because there may be a conflict of interest";
The 8 % " do not know ";
Picture 18
Finally, with the last question, we tried to understand if there was an adequate level of
information about the initiatives promoted by associations of patients in collaboration
with pharmaceutical companies. 96% of respondents said they did not know, while 4%
answered yes, indicating the following responses:
picCommunity, Only those flaunted on TV, Many, through congresses, Viverla Tutta (
PFIZER ) welfare programs .
This last significant result focuses on how much these initiatives could be developed and
strengthened, especially from the point of view of information and effective
communication.
6 CRITICAL ISSUES AND STRENGTHS: OUR VIEWS
In our research, we therefore focused on pharmaceutical companies and patient
organizations that had already understood the power of collaboration, not only to
understand where the attention to this aspect was born, but also to explore what were
the benefits they had derived and what were the aspects that it could be still improved.
Thanks to the study conducted during our research, we were able to summarize what are
the areas for improvement, which Associations and Pharmaceutical Companies should
work on.
In order to make more profitable partnerships between companies and associations, a
suggestion would be to find the best way to enforce the rights of citizens and patients,
trying to pass all the information so as to fully protect the health and rights of all,
investing more in fundraising, and overcoming the passive role of the "receptors " of
funding. In a way that patient associations should not merely depend financially from the
support if Pharmaceutical Companies, but they can take advantage of the all-round
benefit of this collaboration.
In a first step, Pharmaceutical Companies should:
Adapt to an easier and less professional style of communication, considering that they
are not interacting with a doctor but with another party.
Try to find a contact with regulatory authorities (Italian Agency for Drugs Agenzia
Italiana del Farmaco - AIFA - and Regions), activating, enhancing and managing
partnerships and establishing, in accordance with their mutual roles, relations of
confrontation and collaboration from the earliest stages of development of a research
project, in order to contain the risks of investing in projects which will then not have a
market outlet.
On their side patient associations should:
Invest on people-raising in order to expand their base of members to increase their
stability, in order to become competent and knowledgeable spokesperson and be more
credible in the interactive dialogue with Public Institutions.
Have the opportunity to work more closely with regulatory authorities (AIFA and
Regions), in order to be included in decision-making processes.
If the first points depend on the will of the individual parts and consist of processes that
will certainly be developed over time, thanks to the increased awareness resulting from
dialogue and continuous collaboration; the following points require a willingness to
search for interaction by AIFA.
From 2012, AIFA has created AIFA Open, an initiative to give the opportunity to all
stakeholders of the Healthcare system (including Pharmaceutical Companies and patient
associations), to participate in monthly meetings with the agency to discuss questions
and issues put forward by the claimants of the meeting. This is the only opportunity for
associations to be heard, but, in fact, in the process of Health Technology Assessment,
such as the accessibility to the drug theme, they are still not involved.
Another suggestion for the pharmaceutical companies would be not limit the cooperation
with associations of patients in the therapeutic areas in which there is a drug launch or
post-launch, but begin to work through the concept of Early Engagement, involving
associations already in the phases in which the drug is being tested so as to make them
participate in an early stage of development.
This could represent a purposeful change of trend: mapping the world of associations
starting from the companies’ pipeline rather than their pharmaceutical portfolio and
focusing not only on the present, but also on what will come.
This brings us to one of the most difficult steps to do, but that is also the key to the
success, which is to incorporate the point of view of the patient and of the association in
Pharma’s plan of action.
The aim is to be able bring the point of view of the patient from outside to inside the
Pharmaceutical Companies.
To achieve this goal, Pharmaceutical Companies must commit themselves to improving
the Patient Advocacy departments, and then create groups of people with translational
skills, which are able to interact to best. Indeed, one of the main problems encountered
by patient associations, is that of having to communicate frequently with representatives
of the Pharmaceutical Companies that are more related to aspects of marketing or mere
external communication, where the staff is not perfectly formed for these purposes and
further characterized by a high turnover rate.
All this, together with the high level of bureaucracy found in companies does nothing but
slow down the process, as already mentioned in chapter 5.1
Last but not least, we would like to point out once again the issue of transparency of
information already discussed in the chapter 4.4
As we have seen, in the recent past, Pharmaceutical Companies have received precise
regulations to be followed in this area, and, in the future steps, it would be appropriate if
patient associations were also regulated in this regard.
In fact, given that donations from Companies are liberal and unconditional, on their side
associations have no obligation to report the use of the latter, giving room for possible
misunderstandings.
Though there it is hoped that, especially on the part of these organizations, who speak
out the suffering of the sick people, there were no hidden double purpose, it would be
nevertheless appropriate for clarity and transparency, that they would fill out some
report declaring the source of funds, the amount and the intended use.
7 ACKNOWLEDGEMENT
Dott.ssa Stefania Vallone – segretaria WALCE
Dott.ssa Simona Sappia – Communications and Patient Advocacy Manager
Dott.ssa Fanny La Monica - Corporate Communications Director at Pfizer
Dott. Francesco Acampora – Brand Manager Biotest Italia
Dott. Filippo Bresciani - Payor Marketing and Advocacy Advisor at Bayer HealthCare
Dott.ssa Cinzia Colombo – Istituto di Ricerche Farmacologiche Mario Negri – lab. Ricerca
per il coinvolgimento dei cittadini in sanità
Dott.ssa Paola Mosconi – Istituto di Ricerche Farmacologiche Mario Negri – lab. Ricerca
per il coinvolgimento dei cittadini in sanità
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written by: Thomas Forissier, a principal in the life sciences practice at Capgemini
Consulting in New York. (1. Estimated at $564 billion globally in: Estimated Annual
Pharmaceutical Revenue Loss Due to Medication Non-Adherence, Capgemini Consulting-
HealthPrize, 2012; 2. Digital marketing captures a greater “share of mind” among
pharma marketing, says Cutting Edge Information, Pharmaceutical Commerce, January
11, 2012; 3. Watermark Consulting, 2012; 4. The National Progress Report on e-
prescribing and Safe-Rx Rankings, year 2012, Surescripts)
http://www.pfizer.it/cont/pfizer-italia-I-vantaggi-per-il-malato-e-il-SSN/i-vantaggi-per-il-
malato-e-il-ssn.asp
http://www.fivehundredwords.it/post/it-accettabilit-una-dimensione-dimenticata-della-
qualit-delle-prestazioni-sanitarie article written by Ubaldo Montaguti, part of the Section
of Public Health and Health Management at the National Academy of Medicine, of which
he is chief scientist.
http://www.siot.it/documenti/parere/centralitaMalato.pdf
http://www.aots.sanita.fvg.it/aots/infocms/RepositPubbl/table15/1/Allegati/ravignani.pdf
article written by Bishop Eugenio Ravignani
http://www.sanofi.it/l/it/it/layout.jsp?scat=27901DFF-20AA-45D7-88B9-A3267DC34903
http://it.radiovaticana.va/news/2013/06/14/congresso_mondiale_di_oncologia:_la_centr
alità_del_paziente_negli/it1-701408 article written by: Salvatore Sabatino
http://www.bologna2000.com/2012/10/30/la-centralita-del-paziente-nel-percorso-
diagnostico-terapeutico-domani-convegno-al-policlinico-modenese/
http://www.pharmexpand.com/patient-centricity.htm
http://www.quint-essenz.ch/it/topics/1248
Medicina Narrativa per una sanità sostenibile, Maria giulia Marini e Lidia Arreghini
http://www.partecipasalute.it/cms_2/node/387/
www.farmindustria.it/pubblico/01cofait.pdf
http://www.partecipasalute.it/cms_2/node/353
http://www.roche.it/fmfiles/re7143001/collaborare_con_le_associazioni_pazienti_Linee_
guida.pdf
http://www.parkinson-italia.info/epda/partnership.html