Press release

50 years of EU Pharma Legislation

EuropaBio calls for bold policies to promote innovation for biotech medicines.

Brussels, 28th September 2015 

Attending a health conference organised by the European Commission in Brussels today, EuropaBio called on EU policy-makers to continue promoting biopharmaceutical innovation, while maintaining high EU standards for the safety and efficacy of medicines.

The conference, entitled 50 years of EU Pharma Legislation: Achievements and Future Perspectives, explored the history of the EU legislation on pharmaceuticals since its first acts were adopted in 1965 and debated the role of EU public health authorities going forward. Many issues were addressed during the conference, including the topics of access to and safety of medicinal products, the relationship between regulators and industry and the role of legislation in promoting innovation.

“I would like to thank the European Commission for organising today’s conference,” commented Nathalie Moll, Secretary General of EuropaBio. “Europe has clearly come a long way in terms of protecting patient safety and guaranteeing the quality and efficacy of new medicines. We call on the EU drug regulatory network to maintain such high standards in the future while at the same time allowing enough flexibility for the healthcare biotech industry to continue to innovate,” she added. “We need bold measures to cut red tape, particularly for SMEs, and to streamline patients’ access to new and innovative biotech medicines,” emphasised Robin Evers, Senior Vice President Regulatory Affairs, NovoNordisk A/S and Chair of the EuropaBio Healthcare Council.

In recent years, the healthcare biotechnology industry has led to outstanding medical advances resulting in dramatic improvements to the quality of life of millions of European patients.Only 30 biotech medicines had been authorised in Europe until the entry into force of the centralised approval system in 1995. Since then and in only 20 years, that number has trebled with approximately 90 applications for marketing authorisation of biotech medicines having been received by the European Medicines Agency. Biological medicines have become the treatment option for many chronic conditions such as diabetes, anaemia or hepatitis C. They have also become the new standard of care for other diseases such as rheumatoid arthritis or cancer[1] and represent 50% of all medicines in development[2].

ENDS

 

[1]European Medicines Agency 20th anniversary book, March 2015, p. 21 – available at: http://www.ema.europa.eu/docs/en_GB/document_library/Brochure/2015/03/WC500184383.pdf

[2]Valuing Healthcare Biotechnology in Europe: EuropaBio’s perspective, 2014