Position paper on the draft bill to improve the supply of medicinal products
In late July, the Federal Ministry of Health (BMG) submitted a draft bill aimed at improving the supply of medicinal products in the statutory health insurance funds (AM-VSG). BIO Deutschland has drafted a position paper focused on this legislation and also made clear at a BMG hearing in August that introducing a turnover ceiling in the first year after approval would hinder the development of innovative therapies. If the pharmacy retail price of a newly approved drug exceeds €250 million including value-added tax, the reimbursement price that the manufacturer negotiates with the National Association of Statutory Health Insurance Funds will apply from the following month. BIO Deutschland advocates removing this new provision. It affects in particular highly innovative medicinal products that are often in especially high demand. The biotech sector plays a major role in developing such medicinal products. At the same time, BIO Deutschland welcomes the proposed new provisions for taking better account of antibiotic resistances in benefit assessment, in the establishment of maximum reimbursement rate groups and in the regulations to improve the procedure for providing compensation for diagnostics. Further topics touched on by the association in the position paper include, among others, an extension of the price moratorium, the concretization of the possibility to create price-quantity regulations, and revisions to the early benefit assessment in cases where new information is available.