Second Meeting of the Federal Government’s Pharma Dialogue

The focus of the second meeting of the Federal Government’s Pharma Dialogue on 3 June 2015 was on regulating the medicinal products markets and reimbursement issues in Germany.

A the invitation of the Federal Ministry of Health, the meeting was attended by Josef Hecken of the Federal Joint Committee of Physicians and Health Insurance Funds, Johann-Magnus Freiherr von Stackelberg of the National Association of Statutory Health Insurance Funds, and the Presidents of the Federal Institute for Drugs and Medical Devices and the Paul-Ehrlich-Institut, Karl Broich and Klaus Cichutek, along with representatives of medicines manufacturers, biotechnology associations (the German Medicines Manufacturers’ Association (BAH), BIO Deutschland, the German Pharmaceutical Industry Association (BPI), Pro Generika and the Association of Research-Based Pharmaceutical Companies (vfa)), research organisations, and the Mining, Chemicals and Energy Trade Union. BIO Deutschland was represented by Board Member Christian Schetter and Managing Director Viola Bronsema.

A Pharma Dialogue working group, which was set up after the first meeting, presented a paper on antibiotics that explores solutions for incentive systems, improved research funding, better collaboration between science, industry and regulators, as well as training, information for the public and diagnostics.

The Act on the Reform of the Market for Medicinal Products was the first main topic on the agenda, with discussion on its aims of providing patients with the best and most effective medicines, making medicines prices economical and cost-effective, and creating reliable parameters in patient care and in Germany as an innovative country.

The second main topic was reimbursement in the statutory health insurance funds. The discussion focused on regulation issues in the patent-free market, specifically on the increase in the number of regulation instruments during the life cycle of a medicinal product. In the generics market, these instruments simultaneously include, inter alia, a maximum reimbursement rate, rebate contracts, a price moratorium and manufacturers’ discounts. There was also discussion on regulations for adequate market access for new biosimilars in the interests of fair competition, as well as on better linking of medicinal products and tests in the field of personalised medicine, particularly as regards reimbursement.

As regards the quality and safety of healthcare, the topics of counterfeit medicines, treatment safety and supply shortages were discussed. Current initiatives and collaborations showed that good cooperation between policymakers, regulators and industry will enable Germany to rapidly find reliable solutions, should any problems arise as regards patient safety and consumer protection. There was also a presentation on the extent to which the pharmaceutical industry is already helping to make the distribution chain more secure, for example through the project securPharm.