Transparency & disclosure requirements for generics

ritten by: Fleming. Team

How is the generic medicines industry preparing for disclosure in 2018?

Medicines for Europe will continue its close cooperation with its members to ensure a smooth process towards disclosure in 2018. We have several expert groups dedicated to the implementation of the rules that are developing concrete case studies though Q&A updates, sharing best practices and engaging with healthcare community partners aiming for a comprehensive approach to transparency.

What appear to be the greatest challenges?

In pursuing the implementation of our Code of Conduct rules, we are striving to achieve the right balance between meeting public expectations and managing the day-to-day realities and practicalities for our members and the healthcare stakeholder community.

Is the generic medicines industry ready for disclosure?

Medicines for Europe is placing members and external engagement at the heart of the disclosure process. From the drafting of the rules of the Code of Conduct to the design of the disclosure template, we have been working in close cooperation with patients, doctors, payers, public health representatives and industry colleagues. Our dialogue ensures that a common understanding of the rules and their implementation is at the heart of our process to design our Code and other accompanying documents.

How can this disclosure in 2018 change the current shape of the generic medicines industry?

The adoption of our Code of Conduct’s transparency chapter by Medicines for Europe members is a strong signal of their ethical commitment and willingness to further engage in mutual efforts towards common standards in reporting their dealings with patient organizations, healthcare professionals and healthcare organizations.

Our members’ respect for universal ethical rules with their partners in the healthcare community is already long established. In several EU Member States, some of our members already practice disclosure to comply with local rules and regulations or with similar self-regulatory stakeholder transparency initiatives.

We are today very proud to have strengthened our public commitment by harmonizing this set of ethical standards for our industries to contribute to a standard reference in the pharmaceutical sector.

Europe Pharma

Corporate Compliance & Transparency in the Pharmaceutical Industry

Visit event website