Now Online: New Position Papers by BIO Deutschland

Genetic Engineering Act – Motion for a Bundesrat Amendment by the Free State of Bavaria

Further to Bundesrat printed paper 46/11, the Free State of Bavaria submitted a motion for a resolution by the Bundesrat on amending the Genetic Engineering Act at the beginning of February. This calls on the Federal Government to check if current genetic engineering legislation can be more specific. The aim was to ensure that genetically modified organisms in the EU can only be used in the authorised field. Therefore, individuals who market conventional seeds for the first time in Germany should be subject to liability for listing genetically modified seeds.

In its statement on this matter published on 25 February, BIO Deutschland welcomed the initiative by the Free State of Bavaria to campaign for greater legal certainty within the agricultural value-added chain in cases of discoveries of genetically modified organisms in conventional seeds. However, these objectives can be achieved more easily and effectively by implementation in a nationwide general administrative regulation, in which homogenous sampling and measurement procedures are defined and the extent of the measures to be taken in cases of proven genetically modified organisms are laid down. It is not necessary to expand existing liability regulations or – as called for in the motion – to amend the Genetic Engineering Act.

Draft by the European Council on the Implementation of Fundamental Ethical Principles in Translational Biomedical Research

In a statement on the suggestion by the European Council and in response to a request by the Federal Ministry of Education and Research, BIO Deutschland made clear in mid-January that there is no need to draft further new statements on ethics.  Instead, the existing regulations should be referred to and, if necessary, amended.

Ethical principles for biomedical research are already found today in many different standardisations. German biotechnology companies are already currently subject to the Regulation on the Use of Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use, in which Directive 2001/20/EG, among others, was implemented. This regulation prescribes a catalogue of internationally recognised ethical and scientific quality standards, which must be observed in the planning, conduct and recording of clinical trials on people, as well as in the reporting on these trials. Article 3 of Directive 2005/25/EG also states that clinical trials must be conducted in accordance with the ethical principles laid down by the Helsinki Declaration using the ethical principles for medical research on human beings issued by the World Medical Association in 1996. This means that diverse ethical regulations must be observed in the field of biomedical research according to legislation to date.

Statement on the European Union’s Clinical Trials Directive

In the middle of May, BIO Deutschland published a position paper on the EU consultation on the revision of the directive on the approximation of the laws, regulations and administrative provisions of the EU member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (which is known as the Clinical Trials Directive.)

As part of the revision of the directive, simplifications in the conduct and registration of clinical trials have been suggested, which BIO Deutschland welcomes. A joint EU portal for the registration of clinical trials is planned. This portal would allow for the submission of an application that can be inspected both by the responsible national authorities and the respective ethics commissions. All applications would be submitted via the portal. It would not be of relevance whether the clinical trial is being conducted in just one member state or in several member states. There would also be the option to refer to information previously submitted via the EU portal when submitting follow-up applications. This would make it easier to keep the dossier on investigational new drugs up to date. Other sponsors could refer to previously submitted information on the basis of a written agreement. This would make matters far easier, in particular for small and medium-sized enterprises, as would a consistent language when submitting the application.

The concept paper also noted that “ethical, national and local perspectives also require a parallel national evaluation procedure in all cases”. Hence, it is planned that a coordinated evaluation procedure will be introduced, in which the respective national ethics commission will deal with the ethical issues, while the remaining decisions will be made as centrally as possible on the EU level.