The German Ministry of Health recently released a draft bill proposal that would introduce significant changes to the legislation on Orphan Medicinal Products (OMPs) and biosimilars in Germany.
The bill, which has yet to pass the Cabinet for approval, sets out plans for mandatory registries for OMPs and Marketing Authorisations under conditional approval or exceptional circumstances. Importantly, the registries will be designed by the Federal Joint Committee (G-BA, which defines guidelines for health care services that are eligible for reimbursement by Germany’s statutory health insurance fund), not by the pharmaceutical company. Also, it is proposed that, on the basis of these registries, the G-BA restrict reimbursement to only physicians or medical centres that are listed on the registries.
The proposed draft also requires the G-BA to set rules for the uptake of biosimilars in terms of pharmacy substitution. Early talks suggest that the G-BA will assess for each active pharmaceutical ingredient (API) if there should be pharmacy substitution or not.
The timing for adoption is unclear, as the bill has yet to enter the legislative process and might be amended in parts.
We will of course keep a close monitoring on the topic, as its impact on the pharmaceutical legislation in Germany might be substantial.
December 6, 2018