Medicines for Europe calls on the European Council, Parliament and Commission to resist pressure from foreign vested interests to derail the adoption of the Supplementary Protection Certificate (SPC) manufacturing waiver. All parties involved in these discussions are well aware that these foreign vested interests fear the competition from EU biosimilar medicines manufacturers where we have been pioneers and technology leaders in bringing access to biological medicines for patients.

The purpose of the manufacturing waiver is to stop the forced delocalisation of medicines manufacturing outside of Europe while stimulating greater access to medicines at expiry of the SPC. Following thorough discussions with all concerned parties and stakeholders, the Council and Parliament have adopted sound trialogue negotiating mandates to successfully adopt the waiver within this legislature.

The Parliament’s support for EU day-1 launch stockpiling is fully consistent with the data in the Commission impact assessment and related Charles River Associates study and is widely supported by stakeholders in the healthcare community responsible for access to medicines. The same impact assessment and study evaluates the impact on the originator industry to be “0”, as originators would maintain their up-to-five years of extra monopoly after patent expiry granted by the SPC.  The impact assessment states: “An SPC manufacturing waiver for export and stockpiling would be the most effective and simplest option” (EC Impact Assessment, p.105).

Medicines for Europe would like to underscore that equitable access to medicines remains a major challenge for Europe. Therefore, all policies like the SPC manufacturing waiver which can improve our economy, our security of medicines supply and more sustainable healthcare budgets should be welcomed.

Commenting on the situation, Adrian van den Hoven, Director General at Medicines for Europe stated “The SPC manufacturing waiver will bring tremendous benefits to Europe in terms of manufacturing, jobs and medicines access with no demonstrable downsides.  Foreign vested interests  should not be allowed to interfere in a transparent EU legislative process where all stakeholders were consulted and involved. The future of Europe’s medicines supply is dependent on this EU decision and we trust in the resolve of our democracy to do what is right for Europe.”

This table summarises the assessment made by the Commission on stockpiling at pages 46-47 of the Impact Assessment (link to impact assessment: