European transparency going live

The European Federation of Pharmaceutical Industries and Associations’ (EFPIA) Code on the Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations (the Disclosure Code) has now gone live, and member companies in 33 countries within Europe have started to collect data for publication in 2016.

Self-regulation to meet public demand

The collaboration between the pharmaceutical industry and healthcare is constantly increasing and it is essential that the industry interacts regularly with healthcare professionals (HCPs) and Healthcare Organisations (HCOs) to improve patient care and treatment. Collaboration and partnerships between HCPs and HCOs and industry are subject to strict regulation and require all parties to respect high ethical standards.

In recent years there has been growing public interest in the pharmaceutical industry’s relationships with HCPs and HCOs. The public want to ensure that such relationships do not influence clinical decisions and that HCPs can be trusted to recommend, administer or purchase appropriate care and treatments based solely on clinical evidence and experience.

In the US, the Sunshine Act was implemented in 2010 to bring transparency to financial relationships between physicians, teaching hospitals and the pharmaceutical industry. In Europe, the pharmaceutical industry implemented the voluntary Code to enhance transparency by enforcing the disclosure of payments to HCPs and HCOs and thereby meeting the demand from the public and creating greater trust.

The Disclosure Code

By 31 December 2013, each of the EFPIA’s member associations should have implemented the Disclosure Code and transposed the provisions into its national code. The Disclosure Code sets out the minimum standards that apply to all EFPIA member associations in all member states. Member associations have a right to deviate from the Disclosure Code where it conflicts with applicable national law or regulation. The provisions of national codes may therefore deviate from the Disclosure Code.

Member companies are bound by the relevant EFPIA member association’s national code in each European country in which they operate (whether directly or through their relevant subsidiary). If the Disclosure Code has not been transposed into national code, member companies will be required to comply with the Disclosure Code when operating in such country.

From the beginning of 2015, EFPIA member companies have started to collect data on all transfers of value to HCPs and HCOs. The Disclosure Code imposes obligations to disclose transfers of value to HCPs and HCOs, commencing with reporting in 2016 on transfers of value for the
calendar year 2015.

All EFPIA member companies are required to disclose payments and other transfers of value made to HCPs and HCOs in certain categories. The transactions disclosed may, for instance, consist of a consultancy fee for an HCP speaking engagement or a grant to an HCO.

Disclosures are made based on the national code of the country where the HCP or HCO receiving the payment or transfer of value has its principal practice, which applies regardless of whether the transfer of value occurs within or outside that country.

It is a condition of EFPIA membership that member associations adopt all EFPIA codes in full, and that member companies comply with the national codes (even in those countries where they are not a direct member of the relevant member association).

If a member company breaches the applicable code, the member association of the country where the HCP or HCO receiving the transfer of value has its principal practice will sanction the company in question, in accordance with local rules.

Data Privacy

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. In each case and prior to any disclosure, data privacy requirements must be checked at national level (i.e. the jurisdiction of the HCP or HCO receiving the payment or transfer of value) by the member company. Companies are encouraged to obtain consent from HCPs and HCOs prior to disclosure.

A Data Protection Directive was adopted in 1995 to harmonise national provisions on protection of individuals in processing and free movement of personal data within the European Union. The directive was implemented in all EU countries. Each country currently has its own national data privacy requirements based on the directive. In 2012, the European Commission proposed a major reform of the EU legal framework on the protection of personal data. The new EU Data Protection Regulation, currently being drafted, will apply at a pan-European level. As the draft legislation stands, it would allow fines of up to EUR 100 million or 5 per cent of turnover, whichever is greater.

Considerations and work to be completed

Implementation is at different stages across Europe and the pharmaceutical industry faces challenges in ensuring consistency of information and integrating data at a corporate level. Meanwhile, HCPs are concerned about the impact on privacy and on the public perception of their profession.

Member companies have been putting a lot of time and effort into preparing for implementation. Information continues to be gathered, but there is still considerable work to be completed during 2015 in order for member companies and national associations to comply with the Disclosure Code and national codes. Among the most critical components will be addressing data privacy issues and obtaining consent from healthcare providers to disclose their information.