European generics and biosimilars makers adopt disclosure rules

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European generics and biosimilars makers adopt disclosure rules

Generics/General | Posted 19/02/2016 0 Post your comment

The European Generic and Biosimilar Medicines Association (EGA) has published disclosure rules for the generic, biosimilar and value added medicines industry. This builds on the EGA Code of Conduct adopted in 2015.

The new ‘Code of Conduct on Interactions with the Healthcare Community’ outlines mandatory ethical standards and principles that EGA members must adopt when interacting with the healthcare community. EGA members will have one year to implement the disclosure requirements as recording of data will begin in January 2017 to publicly disclose in 2018.

The objective of the new framework is to promote trust, responsible behaviour and respect between pharmaceutical companies, healthcare organizations, patients and patient organizations.

It pins down in detail how companies should deal with patient organizations, such as obtaining signed written agreements, ensuring impartiality of published material, and the importance of transparency and ways to achieve it.

Consultants (healthcare professionals or healthcare organizations) may be engaged on a fee-for-service basis, for example, but care must be taken not to induce them to promote a particular product or influence the outcomes of clinical trials. Contracts must be for the purpose of supporting healthcare or research.

The framework details how companies may support scientific, medical, pharmaceutical and professional education in the communities they serve, the types of meetings they may conduct, who may be invited, and the purpose and nature of any hospitality offered.

Financial sponsorship to third-party organizations is permitted for meetings, events or projects directed at healthcare professionals, as long as events are in line with the company’s therapeutic or business interests. In recognition of their support, the company, for example, may receive commercial advertising opportunities and marketing acknowledgements.

EGA member companies are encouraged to report potential violations of the EGA Code and the procedures for this are outlined in the document.

EGA is a non-profit, non-governmental organization representing industry associations and companies from across Europe.

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Source: EGA