Meeting of the Working Group on Health Policy in Munich
On 10 June 2013, the members of the Working Group on Health Policy met in Munich to discuss the current amendment to the Medicinal Products Act, the state of play on the Act on the Reform of the Market for Medicinal Products, and the efforts towards greater transparency that are currently being made by the licensing authorities.
The Third Law Amending Pharmaceutical and Other Regulations (also called the 16th Medicinal Products Act Amendment) led to renewed calls to tighten the provisions on orphan drugs. In concrete terms, the discussion focused on significantly reducing the turnover threshold for comprehensive benefit assessment for orphan drugs contained in Section 35a of the Medicinal Products Act. Members of the Working Group on Health Policy organised parliamentary events on this topic with the aim of showing that this measure did not make sense from an objective or policy point of view and would send the wrong signal. The development of medicinal products for people with rare diseases involves particular challenges. Orphan drugs are highly innovative medicinal products that help a small number of patients. The additional benefits of these drugs are inspected when the drugs are licensed. This should be taken into account in reimbursement rather than sending the wrong signals by insisting on several double assessments, thus reducing the incentives to conduct research on orphan drugs. The working group convinced the Members of the Bundestag of its arguments and the final version of the 16th Amendment to the Drugs Act did not change the provisions on orphan drugs.
The meeting participants also evaluated the benefit-assessment and negotiation procedures that have been conducted to date by the Federal Joint Committee of Physicians and Health Insurance Funds and expressed criticism of the arbitration on price negotiations following the latest proceedings on the Act on the Reform of the Market for Medicinal Products. The arbitration board’s process uses an algorithm that automatically leads to price savings of around 40 per cent and more. This includes savings on innovations that have received a positive evaluation. The working group’s experts believe that this is not laid down in law and that it results in considerable disadvantages for industrial partners, as seen both in the previous negotiations and in the arbitration procedure itself. The working group plans to conduct further talks on this topic in order to find a suitable solution.
In addition, the meeting participants learned about the proceedings that are pending at the European Court of Justice as a result of the publication of preclinical and clinical data by the European Medicines Agency (EMA). The working group welcomed the rulings that have now been given preliminary legal protection and prohibit the EMA from publishing further data. The working group will observe future developments and join the process via its European partners as required.