A DV I S O RY March 2012

Contacts

Keith M. Korenchuk+1 202.942.5817

Ian Dodds-Smith+44 (0)20 7786 6216

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Adela Williams+44 (0)20 7786 6115

Daniel A. Kracov+1 202.942.5120

Silvia Valverde+44 (0)20 7786 6165

Overview of the Revised International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Code of PracticeThe latest revision of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Code of Practice (Code) was launched on March 1, 2012, and goes into effect on September 1, 2012.1 For the first time, the 2012 Code goes beyond addressing pharmaceutical marketing practices to cover interactions between pharmaceutical companies and healthcare professionals, medical institutions, and patient organisations. Key amendments to the 2012 Code include new sections covering the provision of services by healthcare professionals to pharmaceutical companies, clinical research, support for continuing medical education, and interactions with patient organisations. To assist in your review, we have developed the attached comparative chart highlighting the new aspects of the Code.

BackgroundThe IFPMA Code was one of the first international self-regulation mechanisms in the pharmaceutical industry. It serves as the basis of a flexible structure that allows for more detailed national codes that can impose additional requirements to address specific local concerns. This approach offers the advantage of allowing all companies abiding by the Code to operate on a relatively level playing field, partially harmonising the wide differences between countries’ legal and regulatory systems governing pharmaceuticals. It also provides more complete and detailed guidance than can be provided by case law or statute, and can be updated more frequently to adapt to new areas of concern. For example, the Code was expanded in 2000 to address concerns about the increasing use of the Internet, and again in 2006 to place tighter restrictions on hospitality and gifts to healthcare professionals, including a ban on cash gifts.

1 The revised and prior IFPMA Codes can be found at: http://www.ifpma.org/ethics/ifpma-code-of-practice/about-ifpma-code-of-practice.html. Founded in 1968 and based in Geneva, Switzerland, the IFPMA is a nonprofit organization that represents the research-based pharmaceutical industry, including national and regional industry associations. Its mission includes encouraging policies conducive to innovation in medicine for the benefit of patients, and promoting and supporting voluntary principles of ethical conduct and practices.

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involvement, the need for written documentation, and controls on sponsored events.

Finally, the 2012 Code introduces a requirement for member companies to train all employees in a manner appropriate to their role.2

The Code continues to prohibit pre-approval promotional activities for medicines, company-sponsored entertainment at events, and providing or offering personal gifts to healthcare professionals. The rules governing standards for promotional practices remain unchanged, including the rules on substantiation of promotion, printed materials, reminder advertisements, electronic materials, events involving foreign travel, appropriate venues, hospitality, sponsorship, and guests.

From a procedural point of view, the 2012 Code includes more information on how complaints should be handled under the Code of Practice Operating Procedure (Code Appendix 1) and a new IFPMA Secretariat standard operating procedure, which takes the form of an action list for the processing of complaints by IFPMA (Code Appendix 2). The Questions & Answers section that was introduced in 2006 has been updated to reflect the expanded scope of the Code.

Enforcing the CodeThe process for and implications of the enforcement of the Code remain the same. The IFPMA Statutes require all IFPMA member associations and companies to adhere to the provisions of the IFPMA Code. This means that the promotion of any medicinal product, anywhere in the world, by any company that is a member of the IFPMA or a member of the IFPMA association, should be in accordance with the provisions of the IFPMA Code.

2 Certain activities remain outside of the scope of the Code, such as the promotion of prescription and OTC medicines to the general public, pricing and other trade terms for the supply of pharmaceutical products, promotion and marketing of medicines to commercial customers, non-promotional information, and promotion of medical devices.

The 2012 CodeAs noted, the latest version of the Code has expanded its scope to cover the interactions between pharmaceutical companies, their agents, and other stakeholders. The new Code is based on eight high-level guiding principles for good practice:

� patients’ well-being;

� high standards of quality, safety, and efficacy;

� ethical and appropriate interactions;

� accurate, balanced, and scientifically valid information on products;

� ethical, accurate, balanced, and not misleading promotion;

� respect to patients’ privacy rights;

� transparency of sponsored clinical trials; and,

� adhesion to the spirit and the letter of the codes.

The 2012 version of the Code introduces a new section addressing the issues raised by the pharmaceutical industry’s use of healthcare professionals as consultants and advisors for services such as speaking, chairing meetings, involvement in scientific studies, clinical trials, training, advisory boards, and market research. This provision details the requirements with which bona fide consultancies must comply.

Helpfully, the Code provides a clear distinction between gifts, promotional aids and items of medical utility, eliminating previous references to cultural courtesy gifts, which are no longer mentioned. It also tightens the controls on the use of medical samples, by requiring these to be marked as such.

Despite years of having excluded clinical research from its scope, the updated Code contains a new section on clinical research and transparency of sponsored clinical trials, and it also bans “disguised” promotion. There is also a new provision addressing company support for continuing medical education. Another key element is an entirely new section addressing interactions with patient organisations, which provides rules on the companies’ declaration of

| 3Overview of the Revised International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Code of Practice

If you have any questions regarding the new IFPMA Code, please do not hesitate to contact one of the attorneys listed below, or your

usual Arnold & Porter contact.

Keith M. Korenchuk+1 202.942.5817Keith.Korenchuk@aporter.com

Ian Dodds-Smith+44 (0)20 7786 6216Ian.Dodds-Smith@aporter.com

Adela Williams+44 (0)20 7786 6115Adela.Williams@aporter.com

Daniel A. Kracov+1 202.942.5120Daniel.Kracov@aporter.com

Silvia Valverde+44 (0)20 7786 6165Silvia.Valverde@aporter.com

Jacqueline Mulryne+44 (0)20 7786 6123Jacqueline.Mulryne@aporter.com

IFPMA member associations, under their own codes, handle alleged breaches occurring in their respective national territories. Complaints occurring in countries where there is no national code, appropriate laws or regulations, or where a member company is not a member of the local or regional association, fall within the scope of the IFPMA Code. In these cases, the IFPMA investigates and processes the complaints. If the IFPMA Code is found to have been breached, IFPMA will publish the name of the company concerned and its offenses.

Where no breach is ruled, a summary of the case will be published on the IFPMA website. The information disclosed will include the relevant country and a brief summary of the key facts. The respondent company, the complainant, and products are not named.

The new 2012 Code presents further evidence of a continuing convergence of pharmaceutical compliance practices worldwide, and reflects the growing trends of transparency and the expansion of compliance concerns into areas beyond sales and marketing, such as research and development. Although many companies are already taking a global approach to compliance, the new IFPMA code ratifies—and will likely accelerate—those efforts.

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Heading Current Provision - 2006 Code

New Provision - 2012 Code Comments

IFPMA Guiding Principles on Ethical Conduct and Promotion

Not covered. The following Guiding Principles set out basic standards to inform the 2012 IFPMA Code of Practice which applies to the conduct of IFPMA Member Companies and their agents. This helps ensure that their interactions with stakeholders are appropriate.

1. The healthcare and well-being of patients are the first priority for pharmaceutical companies.

2. Pharmaceutical companies will conform to high standards of quality, safety, and efficacy as determined by regulatory authorities.

3. Pharmaceutical companies’ interactions with stakeholders must at all times be ethical, appropriate and professional. Nothing should be offered or provided by a company in a manner or on conditions that would have an inappropriate influence.

4. Pharmaceutical companies are responsible for providing accurate, balanced, and scientifically valid data on products.

5. Promotion must be ethical, accurate, balanced and must not be misleading. Information in promotional materials must support proper assessment of the risks and benefits of the product and its appropriate use.

6. Pharmaceutical companies will respect the privacy and personal information of patients.

7. All clinical trials and scientific research sponsored or supported by companies will be conducted with the intent to develop knowledge that will benefit patients and advance science and medicine. Pharmaceutical companies are committed to the transparency of industry sponsored clinical trials in patients.

8. Pharmaceutical companies should adhere to both the spirit and the letter of applicable industry codes. To achieve this, pharmaceutical companies will ensure that all relevant personnel are appropriately trained.

An important addition to the new 2012 IFPMA Code is the introduction of eight high-level guiding principles for good practice. These guiding principles position patients’ well-being as the top priority in the activities of the pharmaceutical industry and reinforce the principle of high standards of quality, safety and efficacy of medicines as the key criteria with which to conform. The guiding principles reflect the broader scope of the 2012 Code, which now focuses on the interactions between pharmaceutical companies, their agents and other stakeholders. It also refers for the first time to clinical and scientific research, and the corresponding due respect for the privacy and personal information of patients. The guiding principles make clear that pharmaceutical companies are expected to comply not only with the letter but with the spirit of the Code. Finally the Code emphasizes the importance of appropriate company training to achieve this aim. These changes are in line with the position adopted by the EFPIA Codes, one of which focuses on the interactions between the industry and healthcare professionals, while the other covers the interaction between the industry and patient organisations, and the scope of the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals and the Japan Pharmaceutical Manufacturers Association (JPMA) Promotion Code for Prescription Drugs. Some of the existing provisions in these three regional codes still reflect the previous position of the 2006 IFPMA Code and they may be amended in the near future.

2012 IFPMA Revised Code Comparison

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Heading Current Provision - 2006 Code

New Provision - 2012 Code Comments

Preamble Preamble The IFPMA Code includes standards for the ethical promotion of pharmaceutical products to healthcare professionals and helps ensure that member companies’ interactions with healthcare professionals and other stakeholders, such as medical institutions and patient organizations, are appropriate and perceived as such.

The preamble to the 2012 Code is largely identical to the previous version of the Code, except for this additional paragraph and a reference to member companies and “their agents”. This wording reflects two important changes in the scope of the new code. First, the new Code now covers interactions with healthcare professionals, medical institutions and patient organisations, in addition to the standards for ethical promotion. Second, compliance with the Code is expected not only from IFPMA member companies, but also from their agents.

Scope and Definitions

Scope The IFPMA Code sets out standards for the eth ica l p romot ion of pharmaceutical products to healthcare professionals to ensure that member companies’ interactions w i t h h e a l t h c a r e p r o f e s s i o n a l s a r e appropriate and perceived as such.

The IFPMA Code covers interactions with healthcare professionals, medical institutions and patients organizations, and the promotion of pharmaceutical products.

The simplified wording of the scope of the 2012 Code reflects the new focus on the interactions between companies and stakeholders that has been added to the existing objective of setting out standards for the ethical promotion of pharmaceutical products.

Definitions Definitions “patient organisation” means typically a not-for-profit institution that primarily represents the interests and needs of patients, their families and/or caregivers. “Medical institution” means typically an organisation that is comprised of healthcare professionals and/or that provides healthcare or conducts healthcare research.

Consistent with its expanded scope, the 2012 Code includes definitions for the terms “patient organisation” and “medical institution”. The definition of medical institution is similar to the concept of institution used by the EFPIA Code on the Promotion of Prescription-only Medicines to, and Interactions With Healthcare Professionals. The definition of patient organisation is very similar to the definition used in the EFPIA Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations.

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Heading Current Provision - 2006 Code

New Provision - 2012 Code Comments

Exclusions This Code does not seek to regulate the following act iv i t ies : promot ion of p resc r ip t i on on l y pharmaceutical products directly to the general publ ic ( i .e., d irect to consumer advertising).

- P romot ion of se l f -medication products that are provided over-the-counter (OTC) without prescription.

- Pricing or other trade terms for the supply of pharmaceutical products.

- The engagement of a healthcare professional t o p r o v i d e g e n u i n e consultancy or other genuine services to a member company.

- The conduct of clinical trials.

- The provision of non-promotional information by member companies.

Deleted. This section entitled “Exclusions” has been eliminated from the 2012 Code. Instead of this formal section, a list of excluded activities appear in the questions and answers annex of the Code. The activities specifically excluded in this Q&A annex are: promotion of prescr ipt ion only medicines and OTC medicines to the general public; pricing or other trade terms for the supply of pharmaceutical products; including promotion and marketing of pharmaceutical products to commercial customers; certain non-promotional information and promotion of medical devices.

Basis of Interactions

Basis of Interaction Member companies’ r e l a t i o n s h i p s w i t h healthcare professionals are intended to benefit patients and to enhance the practice of medicine. Interactions should be focused on informing healthcare professionals about products, providing scientific and educational information and supporting medical research and education.

Member companies’ relationships with healthcare professionals and other stakeholders are intended to benefit patients and to enhance the practice of medicine. Interactions should be focused on informing healthcare professionals about medicines, providing scientific and educational information and supporting medical research and education.

In line with the expanded scope of the new Code, “other stakeholders” are added to healthcare professionals as relationships subject the Code’s provisions on interactions with the pharmaceutical industry.

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Heading Current Provision - 2006 Code

New Provision - 2012 Code Comments

Transparency of promotion

Promotion should not be disguised. Clinical a s s e s s m e nt s , p o s t -marketing surveillance and experience programmes and post-authorisation studies must not be disguised promotion. S u c h a s s e s s m e n t s , programmes and studies must be conducted with a primarily scientific or educat ional purpose. M ate r i a l re l a t i ng to pharmaceutical products and their uses, whether promotional in nature or not, which is sponsored by a company should clearly indicate by whom it has been sponsored.

Material relating to pharmaceutical products and their uses, whether promotional in nature or not, which is sponsored by a company, should clearly indicate by whom it has been sponsored. Promotion should not be disguised.

The new wording of this provision states in a simplified and clearer manner that the requirement to disclose sponsorship applies to all materials sponsored by a company, whether promotional or not.

Standards of Promotional Information

Consistency of Product Information

Healthcare professionals in developing countries should have access to similar data to those being communicated in developed countries.

Respecting the requirement that promotion should be consistent with the label and approved uses locally, healthcare professionals in developing countries should have access to similar data to those being communicated in developed countries.

The 2012 Code clarifies that healthcare professionals in developing countries should have access to similar data to healthcare professionals in developed countr ies provided that this is consistent with the locally approved product label.

Interactions with Healthcare Professionals

Events. Scientific and Educational Objectives

The purpose and focus of all symposia, congresses and other promotional, scientific or professional meetings (an “Event”) for healthcare professionals organised or sponsored by a company should be to inform healthcare p ro fe s s i o n a l s a b o u t products and/or to provide scientific or educational information.

The purpose and focus of all symposia, congresses and other promotional, scientific or professional meetings (an “Event”) for healthcare professionals organised or sponsored by a company should be to provide scientific or educational information and/or inform healthcare professionals about products.

The wording of this provision is refined in the 2012 Code to clarify that events must have a scientific and educational objective which does not necessarily involve informing healthcare professionals about specific products.

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Heading Current Provision - 2006 Code

New Provision - 2012 Code Comments

Promotional Information at Events

Promotional information w h i c h a p p e a r s o n exhibition stands or is distributed to participants at international scientific c o n g r e s s e s a n d symposia may refer to pharmaceutical products which are not registered in the country where the Event takes place, or which are registered under different conditions, provided that the following conditions are observed:

- The meeting should be a truly international, scientific Event with a signif icant propor tion of the speakers and attendees from countries other than the country where the Event takes place;

- Promotional material (excluding promotional aids) for a pharmaceutical product not registered in the country of the Event should be accompanied by a suitable statement indicating the countries in which the product is registered and make clear such product is not available locally;

- Promotional material wh ich refe rs to the prescribing information ( indications, warnings, etc.) authorised in a country or countries other than that in which the Event takes place but where the product is also registered, should be accompanied b y a n e x p l a n a t o r y statement indicating that registration conditions differ internationally; and

- An explanatory statement s h o u l d i d e n t i f y t h e countries in which the product is registered and make it clear that it is not available locally.

[Identical wording with the following additional condition:]

- Host country regulations should permit such an arrangement;

The new Code requires a company to only refer to pharmaceutical products which are not registered in the country where an Event takes place when the local regulations of the country where the Event takes place permit this activity. This additional requirement reflects the current position taken by the EFPIA Code.

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Heading Current Provision - 2006 Code

New Provision - 2012 Code Comments

Entertainment N o s t a n d - a l o n e entertainment or other leisure or social activities should be provided or paid for by member companies. At Events, entertainment of modest nature which is secondary to refreshments and/or meals is allowed.

No entertainment or other leisure or social activities should be provided or paid for by member companies.

The 2012 Code has tightened up provisions regarding entertainment, which is now not acceptable even if it is of a modest nature and secondary to refreshments and/or meals. This is in line with the strict approach taken by the EFPIA and PhRMA Codes.

Fees for Services Not covered. Healthcare professionals may be engaged as consultants and advisors for services such as speaking at and/or chairing meetings and events, involvement in medical/ scientific studies, clinical trials or training services, participation at advisory board meetings, and participation in market research where such participation involves remuneration. The arrangements which cover these genuine consultancies or other services must, to the extent relevant to the particular arrangement, fulfill all the following criteria:

- a written contract or agreement must be agreed in advance of the commencement of the services which specifies the nature of the services to be provided and the basis for payment of those services;

- a legitimate need for the services must be clearly identified and documented in advance;

- the criteria for selecting consultants must be directly related to the identified need and the consultants must have the expertise necessary to provide the service;

- the number of consultants retained must not be greater than the number reasonably necessary to achieve the identified need;

- the hiring of the consultant to provide the relevant service must not be an inducement to prescribe, recommend, purchase, supply and/or administer any medicine; and

- the compensation for the services must be reasonable and reflect the fair market value of the services provided.

The 2012 Code includes this important new provision on fees for services, providing examples of activities that healthcare professionals may provide to pharmaceutical companies and the criteria concerning the genuine provision of services. This is a provision that was already present in the EFPIA Code and therefore in many country codes, and that imposes similar generally accepted limits.

Gifts and other items

Promotional Aids P romot iona l a i ds o r reminder items may be provided or offered to healthcare professionals a n d a p p r o p r i a t e admin is t ra t i ve s ta f f, provided the gift is of minimal value and relevant to the practice of the healthcare professional.

Promotional aids of minimal value and quantity may be provided or offered to healthcare professionals if relevant to the practice of the healthcare professional.

The 2012 Code establishes a clear distinction between gifts, promotional aids and items of medical utility. With regard to promotional aids, the new Code establishes not only a limit in value, but also a limit in the amount of promotional aids that may be provided or offered to healthcare professionals. The details of the specific limits in value and quantities are left to the discretion of the implementing country codes.

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Heading Current Provision - 2006 Code

New Provision - 2012 Code Comments

Items of medical utility

Items of medical utility may be offered or provided free of charge provided that such items are of modest value and are beneficial to the provision of medical services and for patient care.

In accordance with local laws and regulations, items of medical utility may be offered or provided if such items are of modest value, do not offset routine business practices and are beneficial to enhancing the provision of medical services and patient care.

The new Code reflects the fact that items of medical utility are not considered acceptable in some jurisdictions and takes a more prudent approach, limiting this activity to those items that would not offset routine business practices or otherwise defray a cost that would otherwise be borne by the healthcare professional.

Cultural Courtesy Gifts

In some countr ies, i f a l l owed under l o c a l law and in accordance with local practice, an inexpens ive g i f t not related to the practice of medicine may be given on an infrequent basis to healthcare professional in acknowledgment of significant national, cultural and religious holidays.

Deleted. The new Code takes a stricter view on gifts than its previous version. Cultural courtesy gifts are no longer allowed. This is in line with a more controlled global compliance approach to the provision of gifts to healthcare professionals by companies in general.

Samples

Samples In accordance with local laws and regulations, f r e e s a m p l e s o f a pharmaceutical product may be supp l i ed to healthcare professionals in order to enhance patient care. Samples should not be resold or otherwise misused.

In accordance with local laws and regulations, free samples of a pharmaceutical product may be supplied to healthcare professionals authorised to prescribe that product in order to enhance patient care. Samples should be marked as such so that they cannot be resold or otherwise misused.

The 2012 Code tightens the controls on medical samples, requiring that samples are marked as such to identify them and to prevent misuse or resale. This is in line with EU legislation and the EFPIA Code, which provide, in principle, no medical samples should be given, except on an exceptional basis. The JPMA Code also contains this restriction on the use of medical samples.

Clinical Research and Transparency

Transparency Not covered. Companies are committed to the transparency of clinical trials which they sponsor. It is recognized that there are important public health benefits associated with making clinical trial information more publicly available to healthcare practitioners, patients and others. Such disclosure, however, must maintain protection for individual privacy, intellectual property and contract rights, as well as conform to legislation and current national practices in patent law. Companies disclose clinical trial information as set out in the Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases (2009) and the Joint Position on the Publication of Clinical Trial Results in the Scientific Literature (2010) issued by the IFPMA, the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Japanese Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA).

This is one of the key new provisions, which expands the scope of the Code into clinical research and the transparency of such research. It requires companies to disclose clinical trial information as provided in the two joint positions issued recently by four key international and regional pharmaceutical industry associations, i.e., IFPMA, EFPIA, JPMA and PhRMA.

Distinct from Promotion

Not covered. All human subject research must have a legitimate scientific purpose. Human subject research, including clinical trials and observational studies, must not be disguised promotion.

This new provision of the 2012 Code aims to ensure that clinical research is not used as a justification for disguised promotion.

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Heading Current Provision - 2006 Code

New Provision - 2012 Code Comments

Support for Continuing Medical Education (CME)

Support for CME Not covered. Continuing medical education (CME) helps to ensure that healthcare professionals obtain the latest and most accurate information and insights on therapeutic areas and related interventions that are critical to the improvement of patient care and overall enhancement of the healthcare system. The primary purpose of an educational meeting must be the enhancement of medical knowledge and therefore financial support from companies is appropriate. When companies provide content to CME activities and programs, such material must be fair, balanced and objective, and designed to allow the expression of diverse theories and recognized opinions. Content must consist of medical, scientific or other information that can contribute to enhancing patient care.

This provision addressing CME has been introduced for the first time in the 2012 Code. The most important implication to note is that under the 2012 Code if a company gets involved in framing the content of the CME activities it becomes responsible for the compliance of such content with the applicable laws, regulations and codes.

Interactions with Patients Organizations

Scope Not covered. The pharmaceutical industry has many common interests with patients organizations. All interactions with patient organisations must be ethical. The independence of patient organisations must be respected.

The 2012 Code introduces a section on interactions with patient organisations. The general principle underpinning this activity is respect for the independence of the patient organisation.

Declaration of Involvement

Not covered. When working with patient organisations, companies must ensure that the involvement of the company and the nature of that involvement is clear from the outset. No company may require that it be the sole funder of the patient organisation or any of its programs.

The 2012 Code requires companies’ disclosure of any involvement with patient organisations and prohibits any exclusivity arrangements between a company and a patient organisation or group of patients organisations. This approach is consistent with the current approach of the EFPIA Code.

Written Documentation

Not covered. Companies that provide financial support or in-kind contribution to patient organisations must have in place written documentation setting out the nature of support, including the purpose of any activity and its funding.

Written documentation supporting financial or non-financial support to patients organisations is also the approach taken by the EFPIA Code.

Events Not covered. Companies may provide financial support for patient organisation meetings provided that the primary purpose of the meeting is professional, educational, and scientific in nature, or otherwise supports the mission of the patient organisation. When companies hold meetings for patient organisations, companies must ensure that the venue and location is appropriate and conducive to informational communication. In addition, any meals or refreshments provided by a company must be modest as judged by local standards.

In line with other national/regional codes, the 2012 Code requires pharmaceutical companies to keep similar high standards with regards to the sponsorship of events in the context of its interactions with healthcare professionals and patient organizations; with regard to acceptable venue, location, and hospitality.

© 2012 Arnold & Porter LLP. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.

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Company Procedures and Responsibilities

Training Not covered. Companies should also ensure that relevant employees receive training appropriate to their role.

The 2012 Code introduces a new requirement for companies to ensure appropriate training for their employees in accordance with their role and in order to ensure compliance with the relevant laws, regulations and codes.

Responsibilities for Approving Promotional Communications

A d e s i g n a te d c o m p a ny employee, with sufficient knowledge and appropriate sc ient i f i c o r hea l thc a re qua l i f i c at ions shou ld be responsible for approving all promotional communications. A lso, a sen io r company employee could be made responsible, provided that scientific advice is taken.

A designated company employee with suf f ic ient knowledge and appropriate qualifications should be responsible for approving all promotional communications. In the alternative, a senior company employee(s) could be made responsible provided that she or he receives scientific advice on such communications from adequately qualified scientific personnel.

This new provision regulating the responsibilities for approving promotional communications focuses on obtaining scientific advice from appropriately qualified personnel as opposed to receiving scientific advice from any source.