Regulatory Experts Meet in Berlin

The experts from the Working Group on Regulatory Matters met in Berlin on 11 June 2013 to discuss clinical trial investigators’ contracts, the state of play as regards the implementation of the Clinical Trials Regulation, the requirements of medicinal products for innovative therapies, companion diagnostics and orphan drugs.

The working group had already discussed clinical trial investigators’ contracts at an earlier meeting and now took the opportunity to address the topic once again as part of the “Dos and Don’ts” information series. Isabelle Kotzenberg reported on her experience of drafting and applying investigator contracts and pointed out the difficulties in drawing up such contracts. After her presentation, the meeting participants discussed whether it would be possible to draft a template for investigators’ contracts in order to help small and medium-sized biotechnology enterprises with their collaboration and discussions with clinics / investigators on clinical trials. The working group will attempt to draft a template, which will be made available to BIO Deutschland members.

BIO Deutschland’s office reported on the current state of play on producing an EU clinical trials directive. The report focused on the amendments decided by the European Parliament’s health committee during the previous week which made two significant changes to the draft regulation. Firstly, the Ethics Commission, which had not previously been mentioned, is to be included in the discussions on the regulation. The idea is to make clear that an ethics committee must be consulted before a decision is made on a clinical trial. Secondly, regulations have been introduced in order to create greater transparency. In this context, the experts from the working group fear that publications on details of studies could lead to massive distortion of competition. The working group will contact other European associations and members of parliament in order to bring about changes to this situation.

The Task Force on Medicinal Products for Innovative Therapies, which comprises some members of the Working Group on Regulatory Matters, took advantage of the meeting to discuss current issues. Classification by the competent authorities remains a problem. The requirements are extremely stringent as a result of safety concerns, but are not based on an objective assessment. The fact that the authorities have generally not had any previous involvement with the products or product categories plays a crucial role in these requirements. While it is fundamentally understandable that the authorities insist on clinical trials being as safe as possible, this must not be allowed to lead to a situation whereby it is no longer possible to further develop products, as this is not in the interests of patients  or companies that conduct research in these fields. If companies are not able to develop medicinal products for innovative therapies economically, they will halt their research. The members of the task force are now planning to set up meetings with the competent authorities.

The meeting participants decided to write a white paper on companion diagnostics in order to highlight current problems and obstacles as regards the development of personalised medicine. They also agreed to pool synergies and to organise a joint meeting on personalised medicine with the Working Group on Diagnostics, which also deals with this topic.

In addition, BIO Deutschland’s office reported on progress in the initiatives at the European level as regards access to orphan drugs for people with rare diseases. The European Commission published a report in mid-April in which it summarised the findings of the EU Platform on Access to Medicines in Europe. This platform called on EU member states, the countries in the European Economic Area, and relevant advocacy groups to take part in a project group. The aim is to develop a concept for coordinated access to orphan drugs on the basis of voluntary programmes between companies and representatives of the competent authorities. The original aim was to set up a pilot project in order to improve access to orphan drugs in Europe, but it was not possible to produce concrete suggestions on this project due to differences in interests. Instead, the report provides a summary of the participants’ joint positions. The plan is to continue the initiative. The Working Group on Regulatory Matters will observe further developments. BIO Deutschland members are welcome to request a copy of the meeting minutes from the association’s office (e-mail:

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