Biotech made in Europe: The EU Biotech Act comes at the right time
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With the draft for an EU Biotech Act I published yesterday, the European Commission is sending a clear signal to strengthen Europe as a biotechnology location. The German Pharmaceutical Industry Association (BPI) welcomes the initiative. It is now crucial that Europe acts quickly and in a practical manner. "The EU Biotech Act comes at the right time," says Dr. Kai Joachimsen, Managing Director of the BPI. "Europe must consistently strengthen innovation, production and value creation at its own location in order to survive in an increasingly globally competitive environment - with the USA and China."
Strong impetus for Europe as a biotech location
The BPI is particularly positive about
- the expansion of biopharmaceutical production capacities in Europe - including the manufacture of biosimilars,
- the reduction of critical dependencies for important precursors and excipients,
- faster approvals for and the use of artificial intelligence in clinical trials
- more efficient regulatory procedures - especially for Advanced Therapy Medicinal Products (ATMPs).
"The EU Biotech Act addresses key concerns of our industry. Many of these measures make the EU more attractive as a location and are also a good signal in terms of security of supply - because they can shorten development times for biopharmaceuticals and facilitate investment decisions by biotech companies," emphasizes Joachimsen.
Adjustments to the supplementary protection certificate (SPC) are also planned to make it easier to plan investments. In future, companies will be able to obtain an additional year of patent protection for biopharmaceuticals - provided they develop, test and manufacture therapeutic innovations in Europe. Currently, protection under the supplementary protection certificate (SPC) is limited to 5.5 years.
Biosimilars: Investments need fair framework conditions
With regard to biosimilars, however, the BPI sees conflicting objectives: "Parallel and partly counteracting regulations - such as the automatic substitution of off-patent biopharmaceuticals in pharmacies - are, however, exacerbating price pressure in many EU member states. If biosimilars, like chemically synthesized generics, are interchangeable, this will provoke a further migration of companies (production sites) to non-European countries. The first effects of this kind can already be seen in the automatic substitution of parenteral preparations. One thing is certain: "Permanent price pressure destroys investment incentives. Without a reliable return on investment, no company will decide to produce in Europe," warns Joachimsen.
EU Biotech Act also includes veterinary medicinal products
"Biotechnology is key to human and animal health. We are pleased that the EU recognizes this connection and that the Biotech Act also wants to promote the development of innovative veterinary medicinal products. This can strengthen veterinary research across the EU and, ideally, ensure sustainable innovation and production structures," says Joachimsen.
Funding is key for growth and scale-up
The BPI also believes that the planned financing instruments set the right priorities: "The EU Health Biotechnology Investment Pilot and the EU Late Stage Capital Booster Pilot provide targeted support for late development phases and industrial scale-up. Europe not only needs good ideas, but also capital for the market launch of companies. These instruments can make the difference here," adds Joachimsen.
Implementation determines success
The BPI will actively support the further legislative process. The goal remains a reliable, investment-friendly framework for research, development and production. "The EU Biotech Act can sustainably strengthen Europe as a biotech location. Europe must now have the courage to act quickly, pragmatically and with industrial policy intelligence," Joachimsen concludes.
Note: This article has been translated using a computer system without human intervention. LUMITOS offers these automatic translations to present a wider range of current news. Since this article has been translated with automatic translation, it is possible that it contains errors in vocabulary, syntax or grammar. The original article in German can be found here.
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