the international pharmaceutical regulatory and compliance congress and best practices forum...
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![Page 1: The International Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum Brussels, June 6-8, 2007 The pharmaceutical industry and the](https://reader036.vdocuments.net/reader036/viewer/2022081603/56649f115503460f94c233f3/html5/thumbnails/1.jpg)
The InternationalPharmaceutical Regulatory and Compliance Congress
and Best Practices ForumBrussels, June 6-8, 2007
The pharmaceutical industryand the regulations
Girolamo Sirchia MD, FRCP Edin
former Minister of Health, Italy
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Starting points
Innovative drugs are of paramount importance for human beings
Medicinal products are ethical goods Regulations
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• Ref.: EFPIA (2006) The Pharmaceutical Industry in Figures
Ref.: EFPIA (2006) The Pharmaceutical Industry in Figures
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Innovative drugs stem from research
Research and development
are mainly designed, managed and paid
by Big Pharma
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1. Critical issues in pharmaceutical innovation
1.1. Research and development investments
1.2. Marketing pressure
1.3. Clinical trials
1.4. Priority medicines
1.5. Accessibility of medicines
1.6. Counterfeit medicines
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1.1. Research and development
investments
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Pharmaceutical R&D costs
are very high on account
of the high attrition rate
during the drug development process
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Ref.: EFPIA (2006) The Pharmaceutical Industry in Figures
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• Ref.: EFPIA (2006) The Pharmaceutical Industry in Figures
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1.2. Marketing pressure
Big investments require big returns Marketing
Marketing is addressed to prescribing physicians but also the involvement of Patient Associations, journalists and the media, politicians and civil servants is not uncommon
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The mainstayof the industry marketing action:
❶ Advertisements directed to physicians
❷ Visits to physicians by sales representatives
➌ Gifts to physicians and their Institutions
➍ Direct-to-consumer advertising (USA)
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A number of cases have brought to
lights an unhealthy relationship
between manufacturers and the
medical profession which demonstrate
how Company practices frequently
cross the divide separating patient
welfare from profit-seeking behaviour
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1.3. The ethical problem of research: Clinical Trials
design and management of trials
the choice of comparators and ATV
drafting of papers by ghost-writers
relations with investigators
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The risks of influencing the results and
only publishing the results desired
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1.4. The ethical problem of research: priority medicines
predominance of drugs
for the most common pathologies
of industrialised countries
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Priority Medicines for Europe and the World (Kaplan and Laing, 2004)
1. Infections due to antibacterial resistance2. Pandemic influenza3. Cardiovascular disease (secondary prevention)4. Diabetes (Type 1 and Type 2)5. Cancer6. Acute stroke7. HIV/AIDS8. Tuberculosis9. Neglected diseases10. Malaria11. Alzheimer disease12. Osteoarthritis13. Chronic obstructive pulmonary disease14. Alcohol use disorders: liver diseases and dependency15. Depression in the elderly and adolescents16. Postpartum haemorrhage17. Smoking cessation
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1.5. Accessibility of Medicines
Access to essential drugs by developing countries:
November 14th, 2000: 4th WTO Conference of
Ministers – Doha DeclarationAugust 30th, 2003: WTO General Council – Decision
December 18th, 2005: WTO Conference of Ministers –
Reconfirmation of the Decision
May 17th, 2006: the EU (Parliament and Commission)
– Regulations on the granting of mandatory licences
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Briefly
The decisions enabled given countries
in a particular state of need
to produce pharmaceutical products
protected by patents
for their own internal needs,
and excluding export sales
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1.6. Counterfeiting of drugs
7% of all drugs sold in the world
are fake
Serious consequences
for public health
and the industries (WHO)
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Frequency of counterfeiting
Less than 1% in developed countries
10 to 30% in Africa, Asia, South America
20% in the States of the former URSS
50% of drugs bought on the web
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Challenges
for pharmaceutical industries
Industry reputation
Operation difficulties
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Industry reputation
• Transparency
• Access to medicines
• Pricing
• Safety
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Operation difficulties
• Cost-containment policy• Bureaucracy• Harmonisation• Pricing and reimbursement criteria• Access to the market• Patent challenges• Parallel importation• Counterfeits• Generics
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(Courtesy of Dr. Thomas Lönngren)
ChallengesChallenges
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2. Recommendations. States should:
2.1. Support pharmaceutical industry to achieve specific targets
2.2. Assure fast pricing and reimbursement procedures
2.3. Control pharmaceutical expenditure
2.4. Develop phase IV studies and improve pharmacovigilance
2.5. Promote independent research
2.6. Promote solidarity
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2.1. Sustain the pharmaceutical industry to increase the production of innovative drugs
Administrative simplification in testing, registering, pricing, reimbursement
Recognition and reward of innovation
Incentives for ATV (premium prices)
Reward of Companies that invest in research and manufacture in the country
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2.2. Pricing and reimbursement
Pricing, reimbursement
and reimbursement access time
within the EU is the prerogative
of single States. This leads to
differences between States
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(Courtesy of Dr. Thomas Lönngren)
In line with EU Directive
in number of days
Average time delay between registration and effective market access
p7-8 – Situation
521
357317
240
220
000
529092
105124
175
227
249315
380478
488495
PolandGreeceSlovakiaBelgiumFranceCzech Rep.ItalyPortugalNorwaySpainHungaryNetherlandsFinlandSwitzerlandIrelandCyprusSwedenEstoniaAustriaGermanyUKUSA
Note In Poland no new innovative products have been reported as reimbursed for the past six yearsSource: IMS, 2004
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The capacity of the national authorities
to recognise an innovative drug
and make it reimbursable with a price
that recognises the level of therapeutic
efficacy is one of the objectives of
the European Pharmaceutical Forum
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The Paediatric Exclusivity Provision (Section 505A of the US FDA Modernization Act, 1997)
Additional 6 months of patent protection in return for performing studies in children
as specified by FDA
A very similar program has been developed and adopted in EU
Has been a success from the perspective of conducting trials for labelling in children
Overcompensates blockbuster products
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It is believed by many that it would be
appropriate for EMEA to propose
a “Geriatric Exclusivity Provision”
to the European Parliament similar to
the Paediatric Exclusivity Provision
and with similar advantages
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In Italy a network of long-term care and
geriatric hospitals is being organized.
More than 5000 beds are available
for clinical trials on acute and chronic
fragile old people
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2.3. Controlling pharmaceutical spending
Natural increase
Appropriate drug use
Drugs for prevention
Aggressive marketing
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The use of drugs for prevention
(statins, smoking dissuaders, etc.)
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2.4. Aggressive marketing
Relations between industry and investigators – Register of Trials
Relations between industry and prescribing physicians
(Should we eliminate the sponsorship of congresses,CME, etc.?)
① Brennan et al, 2006 ③ Am. Med. Ass. J. of Ethics, 2006② The Prescription Project, 2007 R. Smith, ④ 2005
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2.5. Pharmacovigilance (1)
The European Commission believes that the pharmacovigilance system must be
improved
Cooperation between the States is indispensable in order to evaluate in an independent manner relative efficacy and safety in the clinical practice of innovative drugs
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2.5. Pharmacovigilance (2)
The identification, design and prioritization of large phase 4 drug trials of public health importance represent a major medical, social and scientific effort that currently lacks a champion in the USA (Psay and Weiss, 2007)
The Institute of Medicine’s Committee on Drug Safety has proposed a public-private partnership to help define key public health questions that merit investment in large, long-term phase 4 trials (2007)
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2.6. Indipendent research
Given that: ⒜ the research and development of drugs are important
for humankind
⒝ industry is the largest investor in pharmaceutical
research but manages the trials
⒞ high costs require industries to maximise revenues
and thus invest in drugs with the largest market
it is necessary that developed States invest
in independent research
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2.7. Access to essential drugs by developing countries:
The initiatives hitherto implemented
are insufficient
Forms of health aid have
a considerable diplomatic value
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If we continue to believe that the bonds between persons and peoples
can only be entrusted to contractual
market relations without friendship
and without respect for the rights of all
to human values and essential goods
(such as food, water, housing and health),
our fate will be sealed
(His Holiness Benedictus XVI, Message for the World Peace Day, 2007)
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A good start could be
to study arrangements
for making investments
by States and Companies
in favour of countries
with poor economies remunerative
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Conclusion: some political agreements are needed for an international roadmap
1. State investments
Attention to the pharmaceutical industry Independent research Independent pharmacovigilance Supervision on the system’s ethical
compliance Support to developing countries
ctd.
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2. Harmonisation between States (simpler and more harmonised regulations)
3. Independent information for physicians and the public
on the correct use of drugs
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The USA and the EU
should work together
to lead the improvement
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In the EU Vice President Günter
Verheugen has recently proposed
a Commission Communication
pointing to an EU single market
for pharmaceuticals.
A first step in the right direction
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(Courtesy of Dr. Thomas Lönngren)
EMEA roadmap 2010EMEA roadmap 2010
– Safety of medicinal products
– Earlier availability of new medicinal products
– Support to innovation
– Transparency, communication and provision of information
– Reinforcing the EU medicines network
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