Health ministers unanimously approved the European Parliament’s compromise package on the Advanced Therapies Medicinal Products Regulation at the Council of the European Union’s meeting on Employment, Social Policy, Health and Consumer Affairs in Brussels on May 30-31.

The ministers accepted all of the amendments adopted by the Parliament at first reading on April 25. The advanced therapies regulation, which aims to harmonise EU rules for somatic cell therapy, gene therapy and tissue-engineered products, will now be formally adopted once it has been legally and linguistically finalised in all of the official EU languages.

According to the European Association for Bioindustries, EuropaBio, a single legal framework for advanced therapies could come into force by as early as January 2008. The next step will be developing secondary implementing legislation and technical guidelines to take the regulation forward. The European Medicines Agency (EMEA), which will operate a centralised marketing authorisation procedure for advanced therapies, needs to establish a multidisciplinary Committee for Advanced Therapies and fill the current gap in technical requirements for tissue-engineered products.

Decision 'not unexpected'

The Council’s decision was not unexpected. The European Commission had welcomed the parliamentary compromise as “fully acceptable,” while – importantly for the biotechnology and pharmaceutical industries – the Council had shared the Commission’s view that the regulation should not venture beyond the technicalities of harmonising the legislative framework for advanced therapies across the EU.

To the vast relief of industry, the compromise package quashed a late attempt to insert into the text of the regulation ethical amendments drafted by the Parliament’s Legal Affairs Committee.

These had stipulated that the regulation should apply only to “products made of cells for which marketing is feasible in the near future and which do not raise major controversies.” Specifically, they would have excluded from the new rules, on ethical grounds, “advanced therapy medicinal products that contain or are derived from human embryonic or foetal cells, primordial germ cells or cells derived from those cells.”

Instead, any ethical objections around issues such as using human embryonic stem cells for research purposes will now be left to the discretion of the member states.

Benefit to all

In a statement on its first-reading agreement with the European Parliament, the Council said: “Developments in this field are of great importance for future treatment of illnesses. There is, consequently, a large need to create Community rules in order to facilitate innovation, development and clinical use on an emerging market. Both European patients and the European pharmaceutical industry will benefit from rules ensuring, simultaneously, health, safety and equality in the access to the market.”

EuropBio said the advanced therapies regulation gave Europe a “great advantage” in attracting the leading companies researching and developing innovative therapies, and provided the scientific community, patients and industry with a clear and predictable legal framework.

“Europe has been waiting a long time for this regulation and today’s decision by the EU health ministers represents a great leap forward for all those who can benefit from this new generation of truly innovative treatments,” commented Wills Hughes Wilson, chair of EuropaBio’s Advanced Therapies Working Group.