News - December 16, 2022

?️Sounds of Science Episode 10 on Launch Conditionality

Sounds of Science Podcast – Episode 10

Launch Conditionality: The impact on small and mid-sized companies

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. This episode 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 to the show today:

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

This episode is hosted by EUCOPE’s Government Affairs Manager, Victor Maertens. 

You can listen to Episode 10 and all other Sounds of Science episodes using the links below:

Episode Highlights

Thomas Bols, PTC Therapeutics

“Some very exciting technologies like gene therapies need to be administered in specialized treatment centers. These treatment centers are not available for good reasons in every country. So, there is a need to utilise a cross-border health mechanism to bring patients from one country to these countries with specialised treatment centers.”

“We require a regulatory framework for companies, big or small, that focus on innovation. In the end, certainly in the rare disease space, we often talk about the 95% of rare disease patients who don’t have a treatment. I think it’s sort of paramount that any sort of regulatory or legislative environment in Europe stimulates further innovation.”

“Our business depends on very long timelines. Our development timelines take years often longer than a single decade. So predictability and stability are key factors. When you go into early research, you need to know what the frameworks and the environment will be for the next 10 or even 20 years, which is why this predictability is very important.”

Johanna Grames, AOP Health

“It’s truly impossible for smaller companies to run more than 30 reimbursement negotiations based on more than 30 different health technology assessment requirements. This really needs lots of human and financial resources.”

“When Europe is not attractive for innovative companies to create and implement innovation in Europe, we will not choose Europe to be the first market, and European patients will not have timely access to new therapies.”

“Today’s earnings are financing huge and risky R&D investments, an unpredictable and ever-decreasing price development, which is not even considering inflation or currency effects. In other words, if companies’ margins are brought down by a mandatory launch without adjusting the current pricing rules, R&D is simply not possible and innovation will be stopped.”

Alexander Natz, EUCOPE

“Companies and investors need predictability. They need to know how much exclusivity there is in order to make that upfront investment for products to reach the market in four, or five years.”

“The Commission is overestimating the capabilities of small and mid-sized when they say they can simply launch in two years all over the 27 EU countries. Smaller companies have a staff of no more than five to 10 people dedicated to launch products in Europe across different national markets so it’s a significant burden on them.”

“There are solutions on the table, like cross-border healthcare, differential pricing with confidential discounts. Most importantly, we need to make sure that we are not forgetting about the rights of the smaller companies, which have equal rights to bigger companies, especially when it comes to intellectual property (IP) rights.”

If your company would like to put forward a topic for us to discuss or to participate in a future episode, please reach out to our producer, Dante Di Iulio.

For more information about our work on the General Pharmaceutical Legislation or OMP Regulation or how to join our Working Groups, simply visit our Resource page or send an email to