In response to the European Commission Trade Communication published on 18 February 2021. During Covid-19, Medicines for Europe was strongly engaged to ensure continued access to medicines for patients while protectionism, hoarding measures and panic policies undermined these efforts. The emergency has highlighted the need for closer international health collaboration and for governments to work together with industry to balance emergency health measures with free flow of medicine supply chains. Since the pharmaceutical sector is highly regulated, stronger international regulatory cooperation, especially related to generic and biosimilar medicines which represent the overwhelming volume of medicine supplies, would reduce unnecessary duplications for industry and regulatory agencies, and improve equitable access to medicines.

The EU should focus its trade agenda on pharmaceuticals on the following measures:

• Stronger cooperation on supply chain security. While emergency health measures are needed in a crisis, they can unintentionally undermine access to medicines by blocking trade in medicines or their components.  In a joint effort with the WHO and the WTO (to cover health emergency and trade matters), governments should align on specific mechanisms to limit the potential disruption caused by emergency health measures to the medicines manufacturing supply chain. This could be complemented at the bilateral level by extending Good Manufacturing Practice (GMP) mutual recognition agreements with other highly regulated markets starting with the UK.
• Stronger regulatory cooperation. The Commission should promote global generic and biosimilar development programmes to accelerate access to essential medicines and eliminate the unnecessary duplication of regulatory steps.
• Defend open trade.  The EU should vigorously support the opening of medicines procurement markets and oppose with equal vigour the reneging of existing commitments by the US in the WTO Government Procurement Agreement;
• Stronger cooperation on Intellectual Property. Europe has one of the strongest IP system at global level. It is fundamental that any negotiation on IP with third countries is balanced and take into account the market, legal and regulatory environment of both regions. Therefore, in trade negotiations, the European Commission should evaluate the concrete impact of IP on generic and biosimilar medicines access for both parties. In addition, it should be assessed whether the imposition of European IP standards in third countries has a positive effect on export of European manufactured medicines.

Medicines for Europe

Medicines for Europe represents the generic, biosimilar and value-added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe and invest up to 17% of their turnover in R&D investment. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.