Bringing Your Innovations to European Patients

Santoke Naal from IGES at the BIO 2024 International Convention: "It is important to engage much earlier with the HTA-Agencies than before.”

The panel “Europe's Policy Environment and the Impact on the Biotech Sector” analyzed the proposed revisions to the General Pharmaceutical Legislation (GPL) , including changes to regulatory data protection.

The world's largest biotech congress of its kind, the BIO International Convention, had a strong European focus this year, bringing together key European pharma and biotech players, with the participation of the IGES Group, to discuss the latest legal changes in the EU and their implications for the transatlantic pharmaceutical market.

Cooperation between the United States and Europe is crucial to the success of the global biotech industry. In view of the ongoing political changes in the EU, companies are assessing any potential impact on their business in the region. The upcoming changes, in particular the fact that the centralized marketing authorization procedure with EMA is taking place in parallel with the EU-HTA-procedure, are leading to adjusted timelines.

“It is important to engage much earlier with the HTA-Agencies than before. 2 to 3 years before product launch are appropriate” says Santoke Naal from IGES UK. “Real world evidence is more and more accepted by both, EMA and the HTA-Agencies” adds Steffen Thirstrup from EMA. “We learned from the regulatory agencies that government bodies are not monsters, talk to them early and keep it simple” adds Santoke Naal.

From 2025, the clinical evaluation of new drugs in the EU will no longer be carried out nationally at the level of the individual EU countries, but will be gradually transferred to a centralized, EU-wide procedure. This new centralized HTA procedure presents major challenges for innovative pharmaceutical companies, especially if they come from outside Europe.

"The US biotech industry is well positioned globally. Europe remains one of its most important entry markets, although China is increasingly coming into focus. At IGES, we see that innovative biotech companies from the US often have little understanding of the multitude of country-specific reimbursement procedures in Europe. Harmonization of the EU HTA procedures will create clarity. However, it also places high demands on the planning of clinical trials and strategies for product launches," said Naal in the run-up to the event.

The panelists were Matias Olsen, Public Affairs & Policy Manager at EUCOPE, Claire Skentelbery, Director General, EuropaBio, Santoke Naal, Managing Director, IGES UK, Steffen Thirstrup, Chief Medical Officer European Medicines Agency (EMA) and Thomas Bols, Head of Government Affairs and Patient Engagement, EMEA & APAC, PTC Therapeutics. The discussion was moderated by Justin Pine, Senior Director, Biotechnology Innovation Organization (BIO).

IGES has been involved in the congress for many years, with lectures and panel discussions. EU HTA and joint clinical assessments are currently important topics. The companies of the IGES Group participate in public consultations as EU HTA stakeholders. The IGES Group supports all stakeholders in the healthcare sector in the transition to the new procedure.