B. Thurisch’s scientific contributions

In Germany and in the European Union (EU), the requirements for manufacture, registration/ authorization including labelling and pharmacovigilance for homeopathic medicinal products for human use are well balanced in the pharmaceutical law. In this concept, the quality, safety and compliance with the manufacturing requirements of homeopathic medicinal products are guaranteed and well-established. The benefit-risk-ratio is continuously reviewed in the context of pharmacovigilance. At the same time, the regulations on the statement of indications, the special labelling requirements and the pharmacy-only rule in Germany ensure that the patient receives comprehensive information and qualified advice. Following the requirement for method neutrality and scientific pluralism, European and German legislators have created a system, which gives medical doctors and practitioners the option of treating their patients with medicinal products of their choice and also guarantees patients to have access to medicinal products of their choice.

The assessment and monitoring of all pharmacovigilance related issues are carried out by the Pharmacovigilance Risk Assessment Committee (PRAC) which is one of the Committees of the European Medicines Agency (EMA). Part of the responsibilities of the PRAC is the evaluation of any question relating to pharmacovigilance activities in respect to medicinal products for human use in EU-Referral procedures. PRAC recommendations forwarded to the Coordination Group for Mutual Recognition and Decentralised Procedures – human (CMDh) can be adopted by CMDh in an agreement by consensus which is then implemented by competent authorities of the Member States. If an agreement by consensus cannot be reached by the CMDh, the position of the majority of its members shall be forwarded to the Commission to start a binding Union decision-making procedure. Unfortunately, it happened in the past that Member States departed from agreed CMDh positions which caused confusion and work for the industry. In addition, such decisions can have a negative impact on the safety of patients. This is critical, as the aim of such procedures is the harmonised implementation within the EU. In the context of Art. 34 (3) Directive 2001/83/EC the Member States may only implement those measures that are necessary to comply with the decision. Directive 2001/83/EC does not provide options for Member States to impose additional national conditions on the marketing authorisations going beyond the actions contained in the decision.