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The regulatory position on giving promotional aids for POMs to healthcare professionals?

The regulatory position on giving promotional aids for POMs to healthcare professionals?

Recent cases in Italy have highlighted the importance of staying within the law regarding gifts for healthcare professionals. The European Federation of Pharmaceutical Industries and Associations (EFPIA) has a Code of Practice on the Promotion of Medicines, which reflects the requirements of the Community Code relating to medicinal products for human use (Directive 2001/83/EC as amended). The EFPIA Code covers the promotion of prescription-only medicines (POMs) to healthcare professionals.

Q: What does the EFPIA Code contain?

A: The EFPIA Code sets down a minimum standard which national member associations must adopt in their own codes. With regard to European promotion of POMs by a firm located in Europe, the promotion must comply with applicable laws and regulations, as well as both the national code of the country in which the firm is located and the code of the country in which the promotion takes place.
 
Promotion in Europe by a non-European company must comply with applicable laws and regulations, as well as the EFPIA Code and the code of the country in which the promotion takes place. Where there is a conflict between the relevant provisions of two applicable codes, the more restrictive one applies.
 
The first version of the EFPIA Code came into effect on January 1, 1992. Since then, it has been amended to reflect changes in the underlying European
legislation. The last amendment took place in 2004 to reflect the requirements of the Community Code.

Position in UK

A revised Code of Practice for the UK pharmaceutical industry came into force on January 1, 2006. This Code covers the promotion of prescription-only medicines (POMs) to healthcare professionals and appropriate administrative staff, as well as setting out standards for the provision of information on such medicines to patients and the public.

The UK Code was the result of a major review by the Association of the British Pharmaceutical Industry (ABPI), which included consultation with the Medicines and Healthcare products Regulatory Agency (MHRA), the Department of Health, healthcare professionals and consumers. It incorporated the principles set out in the EFPIA Code, which was itself updated in November 2004.

The UK Code is a self-regulatory code of practice for the pharma industry. Although it is not legally binding, it is designed to reflect the relevant legal framework and, if anything, to be more strict.

The Prescription Medicines Code of Practice Authority (PMCPA) is the body empowered to enforce the UK Code and all ABPI-member companies are bound to operate within it. If a third party believes that an ABPI member company has breached the Code, they can lodge a complaint with the PMCPA.

The PMCPA will rule on the allegation, and has the power to require under-takings from a company in breach, as well as to impose fines and to reprimand the offending company publicly for its breach of the ABPI Code.

Q: What does the 2006 UK Code say about gifts?

A: The ABPI Code of Practice incorporated a number of changes, including amendments designed to increase the transparency of relationships between pharma firms and patient groups, and clarification on appropriate levels of hospitality, travel and accommodation provided for healthcare professionals.

Some of the changes related to gifts, or promotional aids, given to healthcare professionals by sales reps as part of the marketing of a particular medicine. Firms may provide promotional aids if they are:

  • inexpensive - at a cost to the company of no more than £6 excluding VAT
  • of a similar perceived value to the recipient
  • relevant to the practice of the recipient's profession. Promotional aids should not be used as an inducement for a sales rep to gain an interview.

The supplementary information to the UK Code of Practice states that promotional aids are more likely to be acceptable if they benefit patient care. Permissible gifts include stationery, such as computer items for business use, and clinical items, such as peak flow meters. A coffee mug is also an acceptable promotional aid.

The UK Code also sets out rules relating to the provision of both medical and educational goods (ie, medical textbooks) or services - such as providing funding for a nurse to assist in a therapeutic review of patients.

The key conditions for such goods or services to be acceptable are that
(i) they must either enhance patient care or maintain patient care and benefit the UK National Health Service and (ii) they do not feature the name of any medicine.

The EFPIA Code provides that 'where medicinal products are being promoted to healthcare professionals, gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons only if they are inexpensive
and relevant to the practice of medicine or pharmacy'.

The gifts should not be for the personal benefit of the healthcare professional, and companies should look to any relevant national code for guidance as to the meaning of the term 'inexpensive' in this context. Guidance issued by EFPIA in March 2006 notes that what is considered inexpensive varies substantially under national codes from Ä1.5- Ä30.

UK court cases

In a case published by the PMCPA in November 2006, a stethoscope was offered as a promotional aid. It was clearly relevant to the practice of medicine, and cost the pharmaceutical company less than £6. The question arose, however, as to what the perceived value of the stethoscope might be to the recipient.

The requirement to assess the perceived value of the gift is new in the UK Code, and is not found in the EFPIA Code. The PMCPA found that, although some stethoscopes could cost more than £6, many do not. The PMCPA also accepted that this stethoscope did not appear, to be expensive.

A second case under the UK Code, which was published by the PMCPA in February 2007, considered the offer of a memory stick. The PMCPA did not express the view that it was an inappropriate promotional aid.

This case did, however, highlight the importance of ensuring that a reply paid card offering the promotional aid makes it clear that, although a sales rep will deliver the item, there is no obligation to grant them an interview.

This accords with the provision in both the 2003 and 2006 UK Codes which prohibits the use of an inducement by a sales rep to gain an interview with a healthcare professional. No breach of the revamped UK Code was ruled.

Position in Germany

In Germany, the provision of promotional gifts is governed by Section 7 of the Act on Drug Advertising (Heilmittelwerbegesetz, HWG). In relation to promotional gifts, this provision was last amended in 2001 to implement the Community Code into German law. The overall framework for promotional activities involving gifts or comparable benefits in Germany shows some peculiarities which should be kept in mind when marketing products in this essential market.

Most importantly, German law contains a general prohibition on the provision of promotional gifts. The giving of promotional gifts is only permitted in specific circumstances.

A careful analysis is therefore needed when planning innovative marketing campaigns in Germany in order to avoid potential criminal liability for a company's directors and officers. Sanctions for the breach of the provisions on promotional gifts range from the payment of a fine to prosecution for bribery.

The standard cases involving inexpensive gifts of a similar perceived value (such as mouse pads, diaries and stationery such as cheap ball point pens) do not pose a problem, but all unusual objects offered as gifts deserve careful legal examination.

Notably, German law does not have a fixed financial limit for the value of the promotional gifts, making it necessary to assess the value to the recipients in each case. Such an assessment of value to the recipient must be made on the basis of objective criteria and not the subjective view of the recipient themselves.

In this regard, it is important to be aware that German law requires that the gift is not only relevant to the practice of medicine but also that it will be used by the recipient in the practice of medicine. This means that the scope of admissible gifts is narrower than in other European countries.

German case law suggests that although items which can be only for purely personal use may be relevant to the practice of the healthcare professional, they will not be acceptable promotional gifts where they will not be used in practice of medicine (such as an inexpensive necklace to take one recent case).

If the promotional gift is of more than 'very low value' (but still inexpensive), German law requires the gift to be clearly labelled. The label must be long-lasting and must contain the name of the sponsoring company and/or the relevant product which the gift is used to promote.

A gift is assumed to be of 'very low value' only if the amount that the recipient would have to pay for the item on the open market is less than Ä0.20-Ä0.50.

Q: What promotional gifts are permitted in Germany?

A: German legislation expressly permits the use as promotional gifts of 'common accessories' to the medical product or medical device supplied, or also other 'usual benefits' (such as the reimbursement of travel expenses for attendance at medical meetings).

In addition, pharmaceutical firms are permitted to provide information on healthcare topics, such as a booklet on healthy lifestyle advice for sufferers of a particular illness, provided that the materials do not promote a specific product.

Position in France

The situation in France is consistent with the laws and practices in the UK. Similar provisions to those of the EFPIA Code relating to the promotion of drugs were enacted in France through the so-called 'Anti-gift' Act of 1993 (as amended in 2002). The general rule under the French Public Health Code is that healthcare professionals are not permitted to receive, either directly or indirectly, any benefits from pharma companies.

Pharma companies are also prohibited from supplying, offering or promising any benefits to healthcare professionals.

There are some very limited exceptions to the prohibition on the provision of benefits to healthcare professionals. The exceptions fall into two categories:

  • the provision of benefits in relation to specific research or training activities (such as the payment of attendance fees or the provision of hospitality), provided that such benefits have been approved by the French General Medical Council
  • the provision of 'inexpensive' gifts.

The French Public Health Code gives no further guidance as to what constitutes an inexpensive gift. However, the French General Medical Council has indicated that it considers the value of inexpensive gifts, provided per year by a pharma company to a particular healthcare professional, should not be more than Ä30 (excluding VAT).

The Ä30 limit represents the cost to the recipient if they were to purchase the gifts in the open market.

Following the implementation of the Community Code, the new provisions of French law provide that, within the framework of promoting medicines to health professionals, it is forbidden to supply, offer or promise to offer any gift unless it is:

(i) inexpensive

(ii) relevant to the practice of medicine or pharmacy.

Q: What types of gifts are permitted in France?

A: The French Health Authority has given some limited guidance as to what types of gifts cannot be given to healthcare professionals by pharma companies. It has stated that toys are forbidden in all cases on the basis that they are not relevant to the practice of medicine and/or pharmacy. Although there has been no guidance as to what the French Health Authority means by toys, it is reasonable to assume that items which are intended for purely personal use and are not relevant to the practice of medicine or pharmacy would not be acceptable gifts to healthcare professionals.

In practice, items such as pens, USBs and calendars are regarded as acceptable gifts to healthcare professionals.

Since the implementation of the Community Code into French law, there has been no case law on the provision of gifts to healthcare professionals. Earlier case law (mainly in 1999) ruled that the following gifts were not permitted:

  • the supply of video equipment for operating room
  • the extension of hospitality to members of a doctor's family.

When planning a pan-European sales campaign, pharmaceutical companies should consider carefully which laws and codes of practice apply to them.

The Authors

Tim Worden is an associate at Taylor Wessing, Cambridge t.worden@taylorwessing.com, Benjamin Grzimek is a lawyer at Taylor Wessing, Dusseldorf b.grzimek@taylorwessing.com, Valerie Budd is a lawyer at Taylor Wessing, Paris v.budd@taylorwessing.com

5th September 2007

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