Brussels, 12 November 2021

The European Parliament Own Initiative Report on an intellectual property action plan is an important step to support the EU’s recovery and resilience following the pandemic and on equitable access to medicine.

The report outlines critical policies to address weaknesses in the current system such as

• Stopping abuses of divisional patent applications that artificially extend the enforceable life of patents and block timely access to generic and biosimilar medicines. 
• Banning patent linkages in Europe that systematically delay generic and biosimilar market entry by linking regulatory decisions to the existence of civil patent rights. This is incompatible with the rationale of the EU pharmaceutical system.
• Revising the Bolar exemption, to allow immediate generic and biosimilar market entry at IP expiry. 
• Assessing the impact of a unitary supplementary protection certificate on timely competition from generic and biosimilar entry. This is clearly driven by the need to ensure that new IP mechanisms do not undermine equitable access to medicine in Europe and that IP titles (and their regulatory extensions) are granted in a transparent and accountable way.

“The European Parliament has clearly voted for a strong and fair IP system by underlining the importance of timely generic and biosimilar medicine competition. The misuse of divisional patents, the need to enlarge the scope of bolar to include API and all regulatory and administrative steps, and the long overdue ban anti-competitive patent linkage are well known problems that the Commission should address in the IP Action Plan. The Parliament has voted; the Commission must act.”, said Adrian van den Hoven, Director General at Medicines for Europe. 

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.