Launch Conditionality: The Impact on Small and Mid-Sized Companies

EUCOPE's Sounds of Science

EUCOPE

Science, Life Sciences

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🗓️ 16 December 2022

⏱️ 38 minutes

🔗️ Recording | iTunes | RSS

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Summary

SOUNDS OF SCIENCE - EPISODE 10

Within the European Commission’s ongoing review of the General Pharmaceutical Legislation and Orphan Medicinal Products (OMP) Regulation, there are several potentially controversial policy options that aim to enhance access to medicine and overcome unmet medical need, including launch conditionality. Under the proposed system, companies would only receive their full Regulatory Data Protection if they meet a number of predefined conditions.

Two conditions under consideration are that companies must launch the product in most, if not all, EU Member States within a fixed timeframe and address a yet unspecified unmet medical need. Today’s discussion focuses on the launch condition, which is far-reaching and creates additional risk for small and mid-sized companies to launch products – particularly orphan medicinal products (OMPs) – in the EU.

Small and mid-sized companies are key drivers of biopharmaceutical innovation in Europe. They play an important role in the development of new and underserved medicines, so it is crucial that their needs and interests are looked after in order to reinforce an innovative and competitive biopharmaceutical ecosystem in Europe. The EU should avoid implementing policy that discourages innovation, disproportionally punishes small and mid-sized companies and might limit, not improve access.

To understand the potential impact of the launch condition on the small and mid-sized health technology company, we’ve invited two of our members on the show today:

Johanna Grames, Senior Manager for International Governmental Affairs and Health Economics at AOP Health
Thomas Bols, Government Affairs Manager, PTC Therapeutics
Alexander Natz, Secretary-General, EUCOPE

Transcript

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0:00.0	Hello everyone and welcome to Sounds of Science.
0:07.0	A series of podcasts hosted by Yukope, a European trade body representing small and mid-sized companies active in health technologies.
0:16.0	My name is Victor Martins. I'm the Government Affairs Manager here at UKope and host on today's podcast.
0:22.6	Before moving forward, if you like this sort of content, please consider subscribing to our channel for more.
0:29.6	And follow us on Twitter and LinkedIn to stay up to date on all the latest news and initiatives in the world of UK.
0:57.0	As we record today, we were on the cusp of one of the most anticipated EU healthcare packages in many years, the review of the General Pharmaceutical Legislation and Orphan Medicinal Products Regulation.
1:02.0	As part of the European Commission's ongoing review of the General Pharmaceutical Legislation,
1:07.0	and Orphan Medicinal Products, or O OMP regulation, there are several potentially controversial
1:13.6	policy options that aim to enhance access to medicine and overcome unmet medical needs.
1:19.6	We'll be discussing one of those here today, namely that of launch conditionality.
1:24.6	Under the proposed system, developers would only receive their full regulatory
1:29.8	data protection or orphan exclusivity if they launch their therapies in all 27 member states
1:36.1	in a fixed and short time frame. While an admirable ambition, such a condition is
1:41.8	far-reaching and creates additional risks for small and mid-sized companies to launch their therapies in the EU.
1:48.0	Small and mid-sized companies are key drivers of biopharmaceutical innovation in Europe.
1:54.0	They play an important role in the development of new and innovative therapies.
1:58.0	So it's crucial that their needs and interests
2:01.1	are also considered as part of the review
2:03.2	to reinforce an innovative and competitive
2:05.2	biopharmaceutical ecosystem in Europe
2:07.4	that ensures that these therapies can make it to patients.
2:10.8	The EU should avoid implementing policy
	...

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