The European Federation of Pharmaceuticals Industries and Associations (EFPIA), based on the Treaty of European Union, represents today most of the pharmaceutical companies in Europe, performing a mainly scientific role. Its purpose is to facilitate the release of medical products in Europe and to work towards the improvement of human health. EFPIA believes that this purpose can be achieved via the economic development of the European pharmaceutical industry, which must be based on full transparency.
Therefore, no eyebrows were raised when its General Assembly approved in June 24, 2013, a Disclosure Code of value transfers from pharmaceutical companies to healthcare professionals (HCP) and healthcare organizations (HCO). The Code is based on the most important principles of corporate social responsibility in order to ensure balance, respect for other pharmaceutical companies, integrity, accountability, immediate response when requested by Member States to clarify costs and the principle of Governance. Each Member Company shall document and disclose Transfers of Value it makes to healthcare professionals (HCP) and to healthcare organizations (HCO) starting from 2016 with transfers of value that were made in calendar year 2015. All members of EFPIA are obliged to fully adopt the Code and to comply with the regulations; otherwise EFPIA can expel them.
A company that has commercial activity in a Member State that has adopted the Code must comply with the Code of that State. If the commercial activity takes place in in a Member State that has not yet adopted in its own legislation the Code, the company is then required to comply with the EFPIA Code as stated in the Federation’s website. The Association of Pharmaceutical Companies (SFEE) incorporated the EFPIA Code in Part B of the Code of Ethics “for the promotion of prescription drug and disclosure of pharmaceutical companies to healthcare professionals and to healthcare organizations”, in order to strengthen transparency, professional ethics and responsibility.
Pharmaceutical companies –members of SFEE- who have their residence or their place of business in Greece, have to publish in a special platform at the website of SFEE the value of transfers to the recipient (name, surname, VAT). Each reference period covers a full calendar year. If the pharmaceutical company is not established in Greece nor has an affiliate company in Greece (where the recipient of value maintains a physical address), it must disclose any Transfer of Value in a manner consistent with the national code to which it is subject. It is clear that the transfer of value to the recipient who was established or has her residence in Europe will be published in the country that the recipient has her establishment or residence, in accordance with the national law of the country.
Disclosures shall be made on an annual basis within 6 months after the end of the relevant Reporting Period and the access to the platform will be free and open. The obligation to disclose concerns the net value of the benefit without any charges (taxes, deductions like ELKE, and other contributions like TSAY); each company will choose whether to publish the net or gross amount depending on the manner with which the document follows the Greek disclosure standards and is posted on the SFEE website. The date of transfer shall be the date indicated in the document.
These disclosures shall be made on an individual basis for each Recipient, in each Reporting Period; or aggregately, if the Recipient has refused the disclosure for an important and serious reason or has revoked his consent later. The consent clause will be part of a written agreement with the recipient and in the absence of a contract will be signed in a separate form.
The disclosures (in an aggregated form) about fees relating to research and development are based on conducting or planning to conduct non-clinical studies, clinical trials and non-interventional studies and activities related to research and development like investigator meetings, advisory boards on clinical research, steering committee and consultancy meetings as well as technical training for clinical studies.
The pharmaceutical companies will subsequently become responsible for the data, inform the Data Protection Authority about the consent of the recipient stating her personal data in order to keep a record of evidence. If the recipient revokes her consent, the company must again inform the Data Protection Authority and modify the data.
Specifically, concerning value transfers to a Health Care Organization (HCO), the following must be disclosed: a) donations and grants either in cash or in-kind benefits, b) grants for events (registration fees and costs) and c) fees for services and consultancy. In the category “cost of collective entries”, the Company must disclose the total expenditure caused by the HCO, in case the PCO makes the decision on the particular HP. In category “cost of grant”, when a HCO assigns the responsibility of organizing an event to a third part (PCO), the expenses are included in the sponsorship agreement and may consist of several activities such as hiring kiosks or advertisements.
For value transfers to a HCP, pharmaceutical companies must disclose: a) any contribution to costs related to events (such as registration fees, travel or accommodation) and b) fees for services and/or consultancy. In the category “registration fees”, the companies must disclose expenses made in favor of HCP in each of the reporting periods. In the category “fees for services and consultancy”, the companies must mention value transfers resulting from to contracts between Member Companies and HCPs, through which the HCPs provide any type of services to a Member Company – or any other type of funding not covered in the previous categories.
Other costs related to the fees for Services and Consultancy, like travel and accommodation, have to be referred in a separate category, unless they are of negligent value. When there is a sponsorship agreement with a third party (PCO) related expenses must be published in the “cost of grants” section. The costs differ from the costs related to travel and accommodation, such as airline tickets, ship tickets, car hire and hotel accommodation; the latter should be disclosed under the section “contribution of costs of events travel and accommodation” – it’s not necessary there to make individual references when there is a group transfer.
There is no need to disclose benefits to research and market services, for the identity of the contributing health care professionals cannot be discerned. However, if the company is aware of the contributor identity, it can then include this benefit in section “compensation for advisory and other services”.
Apart from the above categories, other benefits and/or expenses involving non-prescription drugs (OTC), lunches within or outside the framework of scientific events, medical samples, gifts of negligent value (less than 15 euros) that concern the practice of medicine or normal commercial transaction supplies – all these can be excluded from publication.
Comment from our Office
Member companies of the Hellenic Association of Pharmaceutical Companies (SFEE) are expected to implement the Code changes (Part B), assuming full responsibility for receiving the consent of healthcare professionals and healthcare organizations and for notifying the Data Protection Agency. Even while the obligations officially begin in 2015, there are significant signs on behalf of the pharmaceutical companies that they intend to fully comply with the new legal framework.
Published on Pharma Journal on October 21 2014