The EFPIA Disclosure Code – 10 Facts for Healthcare Practitioners
- In 2016, EFPIA member companies and those members of our member associations will make public details of payments and transfer of value or in kind made to healthcare professionals (HCPs) and healthcare organisations (HCOs) during 2015. The first disclosures will be made in 2016 and will convey information about payments and transfers of value made in 2015.
Why the need for a Disclosure Code?
- In recent years there has been growing public interest in the pharmaceutical industry’s relationships with HCPs and HCOs. Critically, the public want to know that such relationships do not influence clinical decisions and that they can trust their HCP to recommend, administer or purchase appropriate care and treatments based solely on clinical evidence and experience. This demand will be supported by this push towards transparency, which in turn will create greater trust.
- By creating greater transparency around industry’s collaborations and partnerships with HCPs/HCOs, the EFPIA Disclosure Code aims to strengthen the legitimate relationship between pharmaceutical companies and healthcare professionals by making these better understood by patients and other stakeholders.
- As the primary point of contact with patients, the medical profession can offer invaluable and expert knowledge on patients’ behaviour and management of diseases. It is therefore essential that the industry interact regularly with healthcare professionals and organisations (HCPs and HCOs). This plays a big part in increasing the pharmaceutical industry’s efforts to improve patient care and treatment.
Cooperation and disclosure details
- EFPIA believes healthcare professionals and healthcare organisations should be fairly compensated for the legitimate expertise and services they provide to the industry. At the same time, these relationships need to be handled in an open and transparent manner.
- Disclosures are made based on the national code of the country where the HCP/HCO receiving payment or transfer of value has their principal practice. The physical address where the HCP practices or HCO is located should be used as the reference when determining in which country the data should be disclosed. For example, if an Italian affiliate of an EFPIA Member Company engages with a HCP whose practice is in Sweden for an activity in Germany, this Transfer of Value will have to be disclosed under the name of the recipient HCP in Sweden (following the applicable laws, regulations and the national code in Sweden). This ensures that the patient or interested stakeholder can easily find the information regarding transfers of value to an HCP/HCO he/she has an interest in.
- Member Companies must comply with applicable data protection and other laws, which may impose certain limitations on their ability to make disclosures on an individual basis. Data privacy requirements must be checked at national level (i.e. the jurisdiction of the HCP/HCO receiving payment or transfer of value) by member company. This must be done prior to any disclosure. Companies are encouraged to obtain consent from HCPs/HCOs prior to disclosure, and EFPIA and its Member Associations and Companies are working together with HCPs/HCOs to raise their awareness and prepare for the implementation of the Disclosure Code.
- The EFPIA Code applies to all EFPIA members including: Corporate Member Companies; Members of EFPIA Specialised Groups: (i) European Bio-pharmaceutical Enterprises (EBE) and Vaccines Europe (VE); and Member Companies of Member Associations that are not directly members of EFPIA. This includes most major pharmaceutical companies operating in Europe.You can find a list of EFPIA Member Associations and the countries they operate in, here – http://efpia.eu/about-us/membership.
- In some cases a national association may have its own Code already in place – or a country may have legislation governing the transparency of relationship between healthcare professionals and organisations, and the pharmaceutical industry. In case a Member Company is found in breach of the applicable code or Law, the Member Association of the country where the HCP/HCO receiving the transfer of value has his/her/its principal practice would sanction the company in question.
- The EFPIA HCP Code defines HCPs as any member of the medical, dental, pharmacy or nursing professions or any other person who, in the course of his or her professional activities, may prescribe, purchase, supply or administer a medicinal product. EFPIA Member Associations have transposed the EFPIA HCP Code into their national codes. In principle, these codes will provide further guidance on specialities and professional designations that fall into the definition of an HCP, also reflecting healthcare practice in the country – for instance, nurses can prescribe medicines in some countries but are not allowed to do so in other countries.
The successful implementation of this initiative depends largely on the industry and HCP community working in partnership.