What is the European Federation of Pharmaceutical Industries and Associations (EFPIA)?
The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. EFPIA encompasses EU companies committed to researching, developing and bringing patients new medicines that will improve health and the quality of life around the world.
As a member company of EFPIA Bristol Myers Squibb fully supports EFPIA initiatives, which include the EFPIA Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations. We hope that it will serve to create a better understanding of, and ultimately build trust in, the validity of industry interactions with the medical profession.
What are the specifics of the EFPIA Disclosure Code?
On June 24, 2013, EFPIA adopted a code requiring its members to track and publish transfers of value, provided to healthcare professionals and healthcare organisations. The Disclosure Code supplements the requirements of the EFPIA Healthcare Professional Code and EFPIA Patient Organisation Code with requirements for detailed disclosure regarding the nature and scale of the interactions between industry and healthcare professionals and healthcare organisations. The EFPIA Code required its Member Associations to adopt transparency provisions into their own national codes by December 21, 2013.
- The EFPIA Disclosure Code establishes guidelines for EFPIA members to disclose certain Transfers of Value made to healthcare professionals and healthcare organisations. Examples of transactions disclosed include a grant to an healthcare organization or a consultancy fee for an HCP speaking engagement.
- The EFPIA Disclosure Code applies to all EFPIA members, including full members, affiliate members, research-based pharmaceutical companies that have joined one of EFPIA’s specialised groups; and non-member associations and companies that voluntarily adopt the EFPIA Disclosure Code. As a condition of EFPIA membership, Member Associations must adopt all EFPIA Codes in full (subject to local laws and regulations), and Member Companies must comply with the national codes, even in those countries where they are not a direct member of the relevant Member Association.
- Member Companies are required to generate accurate, transaction-level reportable spend reports based on the Transfer of Value categories, using the EFPIA template.
What is the definition of “healthcare professional” in the context of the EFPIA Disclosure Code?
The EFPIA Disclosure Code defines healthcare professionals 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.
What is the definition of “healthcare organisation” in the context of the EFPIA Disclosure Code?
Under the EFPIA Disclosure Code, healthcare organizations have a fairly broad definition that includes hospitals, clinics, medical or scientific associations, organisations, medical societies, and foundations. The organisation’s business address, place of incorporation, or primary place of operation must be in an EFPIA market and it must have one or more HCPs providing services.
What are Transfers of Value?
The term ‘Transfer of Value’ means a direct or indirect transfer of value, whether in cash, in kind or otherwise, made, whether for promotional purposes or otherwise, in connection with the development or sale of medicines. A direct transfer of value is one made directly by a company for the benefit of a recipient. An indirect transfer of value is one made by a third party on behalf of a company for the benefit of a recipient where the identity of the company is known to, or can be identified by, the recipient.
What Transfers of Value will be disclosed relating to healthcare professionals and healthcare organisations?
| Healthcare Professional |
Healthcare Organisation |
|---|
- Registration fees
- Travel
- Accommodation Fees for Service and Consultancy
- Fees for Service and Consultancy
|
- Contribution to cost of events
- Sponsorship agreements
- Registration fees
- Travel
- Accommodation
- Fees for Service and Consultancy
- Donations and Grants
|
What Transfers of Value are excluded from disclosure?
The following are not transfers of value for the purposes of the Code:
- Transfers of Value that are solely related to over-the-counter medicines
- Ordinary course purchases and sales of medicines by and between a company and a health professional or a healthcare organisation
- Samples of medicines
Why the need for a disclosure?
Increasingly, the public wants to know that relationships between the pharmaceutical industry, healthcare professionals and healthcare organisations do not inappropriately influence clinical decisions and that they can trust their healthcare professional to recommend, administer or purchase appropriate care and treatments based only on clinical evidence and experience.
The hope is that the EFPIA Disclosure Code will help patients and other interested parties better understand the legitimate relationship between the pharmaceutical industry, healthcare professionals and healthcare organisations and that this will subsequently strengthen the working relationships.
Will individual healthcare professionals need to give consent for information about their payments to be disclosed?
Member Companies must comply with applicable data protection and other laws. Those laws may impose certain limitations on a company’s ability to make disclosures on an individual basis. Data privacy requirements must be checked at the national level, that is to say, the country in which the healthcare professional or healthcare organisation is located, by the Member Company prior to any disclosure. Subject to local laws and regulations, companies must obtain consent from healthcare professionals and healthcare organisations prior to disclosure.
In accordance with the EFPIA Disclosure Code, Bristol Myers Squibb is obliged to document and publicly disclose details of certain Transfers of Value made to health professionals and healthcare organisations. Additionally, Bristol Myers Squibb is committed to protecting healthcare providers’ and organisations' personal data and upholding applicable data protection laws and regulations. Therefore, Bristol Myers Squibb disclosure of Transfers of Value will occur only with the prior consent and knowledge of healthcare provider partners, where required by applicable protection and laws.
