Codes of practice on promotion and interactions with health professionals
Industry codes and anti-bribery laws govern pharmaceutical companies' promotion and dealings with health professionals, including meetings, consultancy, training, hospitality and gifts. Writers need to identify the applicable jurisdictions and client procedures and keep up with changes that affect content and project requirements.
Scope and responsibility
Even a minor deviation from ethical guidance can have significant consequences for a pharmaceutical company and health professional, damaging reputations and public confidence. Writers developing medical education materials must consider audience, content and timelines while ensuring alignment with appropriate regulations. Good publication practice and the guidelines, regulations and codes governing promotion and industry–professional interactions are central to ethical medical communications, so those working in the sector need to stay informed as guidance evolves.
Association codes operate internationally, regionally and nationally and cover oral and written promotion, journal advertising, internet and electronic communications, and video. Their aim is accurate, fair and objective information supporting independent prescribing and patient care. They also cover service fees, fee and value-transfer disclosures, entertainment, hospitality and gifts.
Examples of relevant instruments listed in 2016 were:
- The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Pharmaceutical Marketing Practices.
- The European Federation of Pharmaceutical Industries and Associations (EFPIA) codes on promotion of medicines.
- The Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals.
- The Association of the British Pharmaceutical Industry (ABPI) Code of Practice.
- Other European national codes, collected on EFPIA's transparency website.
- The UK Bribery Act 2010.
- The US Foreign Corrupt Practices Act.
The two anti-bribery laws have global reach and impose stiff penalties for contraventions involving industry–professional interactions. Companies may have internal operating procedures and codes enforcing applicable external codes and laws, sometimes with broader scope. Industry codes require companies to ensure agencies and other parties acting for them know and comply with industry regulations. Medical communications companies use compliance divisions or programmes to equip accountable staff to implement professional-facing activities ethically.
Code developments and content requirements
IFPMA introduced its international self-regulatory code in 1981; the sixth version in 2019 followed five revisions and banned gifts and promotional aids for prescription-only medicines while shifting from rules to values. EFPIA's 2019 update required national member associations in the EU to apply similar policies to traditional and digital communication. In 2020, PhRMA endorsed responsible sharing of truthful, non-misleading information with professionals and payers through science-based communication, appropriate context and accurate data representation.
Codes and regulations help determine permissible content and requirements such as authorship criteria, disclaimers and abbreviated prescribing information. For promotional activity, companies should follow national association codes both where they are based and where the activity is planned. Promotional content should be accurate, fair, balanced, objective, complete, current, substantiable by approved labelling or scientific evidence, and consistent with the product licence.
The Organisation of Pharmaceutical Producers of India's 2019 guidelines similarly required accurate, balanced, complete promotional material consistent with approved product information and current evidence, without misleading omissions or half-truths, so professionals could judge therapeutic value themselves. Clinical trials and observational studies were to have a legitimate purpose rather than disguise brand promotion. The Medical Council of India's 2016 code prohibited doctors from accepting gifts, travel facilities and hospitality from industry and discouraged public drug endorsement.
WHO's Ethical Criteria for Medicinal Drug Promotion, issued in 1988, prohibited using scientific and educational activities for promotion. Promotional literature collected at an Indian hospital in 2014 met only 50% of those criteria, with no item meeting them all.
Meetings and advisory boards
Industry-supported meetings include standalone and product-launch meetings, advisory boards, satellite symposia, congresses and speaker-training forums. Applicable national and regional rules cover content, distribution of materials, associated activities, speaker selection, venue, honoraria and hospitality. The IFPMA code described in 2016 stated that company-organised meetings directed at health professionals should provide scientific or educational information relevant to the audience.
The IFPMA Code of Practice 2012 addressed consulting services including scientific consulting, market research and advisory boards. By 2016, national industry codes in the UK, US, Canada and Australia had also been updated to set conduct for advisory board meetings.
US pharmaceutical and device codes in 2020
Conflicts of interest can compromise or appear to compromise professional judgement in research and product marketing; even baseball tickets offered to a clinician may appear to influence future purchases. Appropriate marketing and collaboration can support patient access to products, but interactions should not appear inappropriate or self-serving or compromise either party's integrity. Compliance can maintain transparency and avoid conflicts that jeopardise collaboration and advances in medical science and technology.
The PhRMA code took effect in 2002 and encouraged voluntary compliance; the Advanced Medical Technology Association (AdvaMed) code originated in 1993 and bound its members. In 2020, compliance with AdvaMed guidance was mandatory in states including California, Connecticut and Nevada. Both codes had been revised by 2020. The separate device code reflects the more hands-on relationship between devices and professionals, although many provisions parallel the drug code. Neither code replaces stricter laws, regulations or codes.
Topics addressed across the two codes in 2020 included representatives' informational presentations and accompanying meals, entertainment and recreation prohibitions, support for continuing medical education and third-party educational or professional meetings, company business meetings, consultants, speaker programmes and training, and educational versus noneducational or practice-related items.
They also included company-conducted training, business courtesies, educational and research grants, charitable donations and commercial sponsorships, demonstration, evaluation and consignment products, professionals on formulary or clinical-practice guideline committees, health economics and reimbursement information, scholarships and educational funds, prescriber data, independence and decision-making, and company representatives' training and conduct.
Consultancy and research agreements
Consultants provide information on markets, products, therapeutic areas and patient needs, helping companies develop and market products that meet those needs. Selection and retention should use defined criteria such as expertise, reputation and therapeutic-area knowledge and experience, with continued efforts to avoid inducements or rewards for prescribing or recommending products. Reasonable compensation, including reimbursement for travel, lodging and meals incurred during services, should reflect fair market value. Clinical research services must serve a legitimate research purpose and should have a written agreement and fair compensation.
Company training and third-party support
Companies are responsible for product training covering features, services and potential adverse events; professionals receiving it must be qualified to prescribe the drug or use the device. The setting must enable effective information transfer, while hands-on technical training should use training facilities, medical institutions, laboratories or other facilities. Trainers should have appropriate qualifications and expertise, including field sales staff with the necessary technical skills. Modest meals and refreshments may accompany programmes but should remain secondary to their educational purpose.
Third-party scientific and educational meetings can improve patient care, making company financial support appropriate. Support may take four forms:
- A grant to the conference sponsor to reduce costs.
- An educational grant reducing the educational component's cost.
- A grant to a training institution.
- Commercial sponsorship enabling students, residents, fellows and other professionals who will be trained on the product to attend.
Charitable donations may support patient education, indigent care or events whose profits are intended for charity.
Gifts, entertainment and product evaluation
Companies should not provide or pay for entertainment or recreation for health professionals who are not employees, including theatre or concert tickets, sporting events or equipment and vacations. This applies regardless of value, speaker or consultant status, or whether entertainment is secondary to education. Gifts such as alcohol, flowers, chocolates, holiday gifts and cash or equivalents may not be provided.
Items benefiting patients or serving education should have fair market value below $100, except educational medical textbooks or anatomical models that may exceed this. Items cannot serve noneducational or nonpatient purposes or be used by family, friends or office staff; noneducational branded pens and notepads are prohibited, while product samples for patient use may be appropriate.
In certain circumstances, reasonable quantities of single-use products or multiple-use capital equipment may be provided free for evaluation or demonstration. This lets professionals assess function and appropriate use before deciding whether to use, order, buy or recommend a product; evaluation products are typically expected to be used in patient care. Such provision can improve care, safe product use and patient awareness and educate professionals.
AdvaMed additions
Three AdvaMed sections effective 1 January 2020 addressed jointly conducted education and marketing, communication of off-label claims and company personnel in clinical settings. The latter two headings were “Communicating for the safe and effective use of medical technology” and “Representatives providing technical support in the clinical setting”.
Keeping current as an independent writer
Company procedures and client recommendations often guide medical communications work, and a freelance assigned one part of a project may not need to consult guidelines for that task. Writers nevertheless have an obligation to stay current with changing codes and relevant laws, despite the additional demands of business ownership.
Ways to stay informed include:
- Checking IFPMA and EFPIA websites during quiet periods and at the start of particular tasks or as needed.
- Using EQUATOR for information on publication ethics.
- Consulting EMWA, ISMPP and similar association websites, webinars, publications, bulletins and annual meetings.
- Joining relevant LinkedIn groups, including EMWA, ISMPP, The Publication Plan and MedComms Networking.
Some clients require informal on-the-job compliance training before assignments, especially when a freelance supports a project's full life cycle; although likely atypical, such training can be valuable.