What Can We Expect from Health Policy in 2023?
The start of a new year is traditionally a time for good resolutions and setting goals for the year. In politics, this mainly means retreats of the Bundestag parliamentary groups and updates to the ministries’ work plans. Before political Berlin had properly woken up, the Federal Ministry of Health (BMG) had already done this. On 5 January, the ministry published the main content of its first package on outpatient care: the Healthcare Provision Acts I and II (Versorgungsgesetze I und II). They contain a number of other plans of the traffic-light coalition. Together with the work plans of the Bundestag parliamentary groups, public statements by Health Minister Lauterbach and the BMG’s work plan from November of last year, they give a first indication of what legislation we can expect in 2023.
Key topics: care, digitalization, pharmaceuticals, hospital reform and cannabis
The five big topics for businesses in German health policy will be outpatient care, digitalization, pharmaceuticals, hospital reform and the flagship project of cannabis legalization. While these are the main focus, this does not mean there won’t be detailed rules in other areas of the health sector. Since almost every health policy law is an “omnibus law,” rules affecting individual companies are often included in laws with a different main topic. Continuous monitoring of health legislation and direct engagement with the actors involved therefore remain essential.
Outpatient care
Outpatient care will remain a contested topic throughout the year. The BMG’s plans so far mainly contain many of Minister Lauterbach’s and the Greens’ favorite projects. The minister’s main projects are therefore to be tackled as early as January (Healthcare Provision Act I): health kiosks, faster allocation of doctor’s appointments and making it easier to set up municipal medical care centers (MVZ). The Greens managed to include their topic of health regions. Giving the federal states a role in the doctors’ licensing committees can be seen as harmonizing existing rules in some states, and it makes the allocation of doctor’s practices even more political.
The second half of the year will then deal with the traditional question of how much private capital should be in the health system. From summer 2023, the Healthcare Provision Act II will restrict the rules on setting up, licensing and running “investor-owned” MVZ. Rules on artificial insemination and cryopreservation will also be adjusted from a social policy perspective, and reimbursement will be changed. This is an opportunity for many start-ups working to bring Germany up to standards comparable to those in the US or UK.
Digitalization
Last year, the federal government and the BMG each presented their own digitalization strategy or started work on one. In spring, the BMG plans to present the final report on its digitalization strategy for the health sector. The document will set priorities and projects. Selected actors in the health sector have already been involved. Once the strategy is presented, it will lead to a concrete legislative process: a Digital Act, whose main project will be introducing an opt-out system for the electronic patient record (ePA). If the data protection issues around the e-prescription are also resolved during the year, two key steps for the digitalization of the health sector could be taken. Wider use of the e-prescription and the ePA would then only be a matter of time.
According to the government’s plans, Germany will move unusually fast on the use of health data. Key points for a Health Data Use Act, which provides for a national health data space, are to be presented in the first half of the year. Once the EU regulation on the European Health Data Space is finalized, the German data space is to be connected to the European one. The devil is in the details here. Companies that collect and process health data are well advised to get involved in these processes in order to secure business opportunities and reduce risks.
Pharmaceuticals
The major pharmaceutical reform was already included at the end of last year in the Statutory Health Insurance Financial Stabilization Act (GKV-Finanzstabilisierungsgesetz). Its measures include stricter pricing rules following the benefit assessment, lowering the revenue threshold for orphan drugs to €30 million, an additional mandatory discount for combination products, an increase in the manufacturer discount by 5 percentage points and an extension of the price moratorium. These are meant to benefit the overall financing of the health system. However, the impact on pharmaceutical innovation in Germany will be enormous. How strong the changes to AMNOG (Germany’s drug pricing and benefit assessment system) really are will be evaluated by the end of 2023. So far, the German Association of Research-Based Pharmaceutical Companies (vfa) expects that 45 new medicines could still come onto the EU market in 2023, especially in oncology and infectious diseases. As a reference market for prices in other EU countries, Germany is clearly losing appeal because of these rules. A fundamental reform of statutory health insurance financing could counter this. Recommendations are expected in May and will then feed into the budget process for 2024.
Germany was once the “pharmacy of the world.” The recent shortages of children’s medicines show that this is no longer the case. In December, the BMG therefore presented key points on drug shortages and on strengthening the EU as a production location. In the second or third quarter, a Generics Act is to follow. It is meant to address shortages of low-margin medicines that are no longer worth producing in Germany. Ideally, this law will include rules to strengthen Germany as a location for pharmaceutical production, for example for new manufacturing methods. Whether this happens through an IPCEI Health, for which a total of €185 million has been set aside in the budgets of the coming years, or by defining which medicines are “system-critical,” will certainly be debated this year.
Hospital reform
Reforming Germany’s hospital structure is another flagship project of the health minister. After setting up the Government Commission for a Modern and Needs-Based Hospital Care to fundamentally reform hospital financing, the ministry began talks with the federal states on the details at the start of the year. Lauterbach stayed true to his general approach of first getting scientific expertise without directly involving the relevant actors at the first stage. The BMG is mainly focused on moving away from flat-rate payments per case (DRGs) as the only system, planning hospitals by services instead of by departments, and loosening the line between outpatient and inpatient care. The federal states, on the other hand, want to keep their planning authority. However, the first signals after a federal-state conference in January point to constructive cooperation. Whether and how the commission’s proposals will lead to real, concrete changes will be discussed throughout the year. Private hospitals in particular should get involved in the process.
Cannabis
On cannabis legalization, everything currently depends on the European Commission’s preliminary review of the key points submitted. If there are positive signals from Brussels, the BMG plans a draft bill for the third or fourth quarter. The draft is currently being prepared in the ministry. Besides questions about selling cannabis for recreational use, the line between recreational and medical cannabis will continue to be discussed this year. Many companies are ready to bring their products to market or develop them further. The detailed rules on prescribing cannabis are one of the main issues. The latest move by the Federal Joint Committee (G-BA) tightened the rules for prescribing doctors rather than relaxing them.
So what can we really expect in 2023?
Overall, it will be a busy year for health policy. The health minister has set clear flagship projects and priorities that matter to him. However, health policy remains an area where almost any law can include changes to Social Code Book V (SGB V), the law governing statutory health insurance. It is therefore always worth looking at the details and talking to the relevant experts, in order to find business opportunities and prevent potentially harmful rules. Getting involved in processes early and in detail remains essential.
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