Biotech Industry Calls for Improvements in the EU Regulation on Clinical Trials

At the end of August 2012, BIO Deutschland submitted a statement on the new EU proposal for a regulation on clinical trials (COM(2012) 369 final) to the Federal Ministry of Health. In the statement, the association called on the ministry to formulate patient safety measures and improvements in patient care using innovative medicinal products in a way that does not exclude innovative small and medium-sized enterprises (iSMEs) from the market.

The aim of the EU proposal for a regulation on clinical trials on medicinal products for human use is to create a standardised and efficient European process that will ensure rapid and safe access to new, innovative treatments. BIO Deutschland expressly welcomes this approach. However, the biotechnology sector association sees a need for improvement in the drafting. Among other measures discriminating against iSMEs, the proposal includes wide-ranging information and documentation requirements for auxiliary medicinal products (unlike the tested investigational medicinal products), although these have already been authorised on the basis of a documented process. Rather than duplicating work, existing documentation should be used here. In addition, payment for the use of previously authorised auxiliary medicinal products should be continued.

“The dual information and documentation requirement is only one of many points in the EU proposal for a regulation where it becomes obvious that the European authorities have missed their target,” said Markus Hofbauer, chairperson of BIO Deutschland’s Working Group on Regulatory Matters. “Many of the new points will generate further bureaucracy and increase the costs of clinical trials. iSMEs will be most adversely affected, as the majority of them will no longer be able to afford to conduct clinical trials. As a result, there will also be a negative impact on patients, who will have to manage without new medicinal products.”

For example, the proposal for a regulation aims to improve the existing difficulties involved in multinational clinical trials. BIO Deutschland believes that the proposal should have focused to a greater extent on orphan drugs. By their nature, this group of medicinal products, which are often developed by iSMEs, only benefit a few patients due to the low (rare) occurrence of the disease in the population. In general, such patients are spread far across the individual EU member states. It is therefore crucial that the available test persons can be easily included in clinical trials on orphan drugs. The welcome planned possibility of extending clinical trials to further member states would lead to significant improvements in clinical trials on orphan drugs if certain provisions in the proposal for a regulation did not create considerable work for investigators and sponsors.

In comparison with other European countries, German biotechnology companies hold a strong position in research on medicinal products. Among other things, these companies are involved in transferring technology from science to industry. This means that the more progress they make in their research, the more likely it becomes that new products will reach the market and be available to patients.

The new EU regulation will repeal the Clinical Trials Directive (2001/20/EC). The European Parliament and the European Council will discuss the proposal after the summer recess. The new regulation is scheduled to enter into force in 2016.

A copy of the statement submitted to the Federal Ministry of Health is available in German at

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