When the heads of the Social Democratic Party, the Green Party and the Free Democratic Party presented the coalition agreement of the newly elected German federal government on November 24, 2021, healthcare and the life sciences sector formed one of the focal points. Dr Christian Lebrecht, Associate, and Dr Arian Gruener, Associate, PG Pharma, at multinational law firm, Baker McKenzie, outline the health-related plans of the new German three-party coalition.
From driving forward the digitalization of the healthcare market, ensuring the sufficient supply of medicinal products and vaccines, and more restrictions on the prices of medicinal products, to strengthening pharmacies in underserved areas and legalizing recreational cannabis, the new government has set itself a substantive health agenda for the next four years.
Companies that are active in the field of healthcare and life sciences should closely observe the further developments and be prepared to quickly adapt to new regulatory frameworks and to seize new opportunities.
Digitalization and health data use
- Digitalization in the healthcare sector will be promoted by the introduction of more regular telemedicine services such as virtual consultations, telemonitoring, online emergency services, and electronic prescriptions.
- The introduction of electronic patient records, for which legislative foundations have already been laid and is approaching implementation, will be accelerated.
- Improved scientific use of health data in compliance with the General Data Protection Regulation (GDPR) and the development of a decentralized research data infrastructure will be ensured by the Register Act (Registergesetz) and the Health Data Use Act (Gesundheitsdatennutzungsgesetz).
Supply of medicinal products and vaccines
- Measures will be introduced to avoid supply shortages, and to ensure a sufficient supply of medicinal products and vaccines.
- To ensure the security of supply, incentives will be put in place to encourage the production of medicinal products and active pharmaceutical ingredients (APIs) in Germany or the EU. Measures to relocate production back to the home market include a reduction of bureaucracy, potential investment subsidies for production facilities, as well as the consideration for other subsidies.
- To avoid any conflict of interest, greater transparency on financial contributions made to healthcare professionals and medical aid providers will be ensured.
- To ensure sufficient funding in the German healthcare system, the price moratorium (no reimbursements by statutory health insurances in the case of one-sided price increases by pharmaceutical entrepreneurs, except for adjustments for inflation) will be maintained.
- The ability of health insurances to limit the prices of medicinal products will be strengthened. The negotiated reimbursement price applies from the seventh month after market entry.
- To promote outpatient care, new remuneration schemes will be implemented by means of hybrid Diagnosis Related Groups (DRGs).
Controlled supply of cannabis
- The controlled supply of recreational cannabis to adults in licensed shops will be legalized. Until now, cannabis was only allowed to be used for medical purposes in Germany.
- Pregnancy conflict counselling will be possible online.
- Doctors will be able to provide public information on abortions. Section 219a of the Criminal Code (Strafgesetzbuch) shall be repealed.
- Health insurance funds will be able to reimburse contraceptives.
- Research funding for contraceptives will be increased.
- Pharmacies in rural areas will be promoted and liberalized.
- Remuneration of pharmacies will be optimized by means of broader-based funds.
- Incentives for pharmacies to include medical services in their portfolio will be created through special remuneration models.