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Opinion Piece - Medicines for Europe

Updated: Dec 16, 2019

Words by Adrian van den Hoven, Director General, Medicines for Europe

Europe Now has a Chance to Take on International Competition and Secure the Future of its Pharma Industry

– but EU talks risk further weakening proposals

The generic and biosimilar medicines industry needs sustainability and a workable manufacturing framework if we’re going to be able to continue increasing access to quality treatments in Europe. Better access to medicines is a major challenge, but there is a new EU legislative proposal for a Supplementary Protection Certificate (SPC) manufacturing waiver that could be monumental in ensuring generic and biosimilar medicines are available in a timely manner.

This waiver, proposed by the European Commission in May 2018, could be in jeopardy however, as vested interests and national lobbying start disrupting EU talks. And with €90bn worth of blockbuster first-generation biologic drugs coming off patent in the EU, now is the time to be ambitious. The intention of the waiver is to level the playing field and encourage timely generic and biosimilar medicines competition. It would allow manufacturers to produce medicines in Europe during the SPC period, which is an additional form of protection on originator medicines beyond the original patent.

As the representative association of Europe’s generic, biosimilar, and value-added medicines industry, Medicines for Europe knows all too well the impact of the current process on our members, who account for over 60% of the medicines prescribed in the EU. Our generic and biosimilar medicines contribute to accessible, cost-effective, and safe care, and increased options for prescribing and primary care physicians, which ultimately leads to better disease management.

The continued lack of an SPC waiver creates a geographical disparity in the availability of generic and biosimilar medicines. Manufacturers based in non-EU countries where SPC protection does not exist, or where additional protection is shorter in duration, can enter unprotected markets up to 5 years earlier than EU-based manufacturers, forcing EU manufacturers of generic and biosimilar medicines to move their production outside the EU to overcome these legal hurdles and stay globally competitive.

While a welcome step in the right direction, the European Commission’s proposal remains a small step and not fully workable for the EU generic and biosimilar’s industry. It currently doesn’t provide for manufacturing of medicines for ‘Day 1 launch’ in Europe and wouldn’t be immediately applicable to existing SPCs. It also requires the disclosure of commercially confidential information, which in essence is anti-competitive. The only way to deliver on the promised benefits of an SPC manufacturing waiver would be to make it fully usable by the generic and biosimilar medicines manufacturers that it rightly aims to boost.

The European Parliament and Council now have the possibility of improving the Commission proposal by including manufacturing for Day 1 launch and eliminating any anti-competitive notification procedures. We urge them to be ambitious and to deliver a future-proofed solution for European medicines.

The introduction of a comprehensive EU SPC manufacturing waiver would increase freedom of prescription for physicians, thereby ensuring patients get the best quality of care, while also contributing to healthcare sustainability.

This move would allow Europe to unlock significant economic opportunities – by creating an additional 25,000 jobs and 100,000 indirect jobs

Furthermore, this move would allow Europe to unlock significant economic opportunities – by creating an additional 25,000 jobs and 100,000 indirect jobs, generating a further €9.5 billion in added net sales per year, and reducing pressure on EU Member States’ medicines budgets through a well-functioning framework.

Medicines for Europe remain willing and committed to working with all stakeholders to ensure a comprehensive SPC manufacturing waiver boosts competitiveness, so the European medical community can continue to provide better access and better health for all patients.

For more information please follow us at

and on Twitter @medicinesforEU

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