Germany

Last week, on 4 July 2024, the German Parliament (Bundestag) has passed significant changes to the country’s drug pricing and reimbursement laws. Just six months after the German Federal Health Ministry (BMG) presented a first draft bill for a “Medical Research Act” (Medizinforschungsgesetz or MFG), the German Parliament has now accepted a modified version of that bill. The Medical Research Act mainly amends (1) national laws for clinical trials with drugs and medical devices, (2) rules for ATMPs (3) drug pricing and reimbursement laws (AMNOG) and (4) initiates a re-organization of the regulatory agencies and ethics committees.

In this blog, we take a closer look at the much-discussed changes in the German drug pricing and reimbursement area. We will focus on two key elements:

  • The controversial new feature of “confidential reimbursement prices”; and
  • The new link between drug pricing and local clinical trials which offers pricing incentives for companies that can show that a “relevant part”  of the clinical trials for a new medicine were conducted in Germany.

We had noted in an earlier blog that the German rules for pharmaceutical pricing and reimbursement are among the most complicated legal areas in the entire world of life sciences laws. With the now coming new laws, Germany adds some additional complexity to its system.

1. Background

The discussed changes to the German drug pricing and reimbursement laws are part of the German Government’s new National Pharma Strategy that aims to enhance Germany’s attractiveness as a place for pharmaceutical research, development, and manufacturing. The Government presented an underlying strategy paper in December 2023 and the Medical Research Act is the first legislative implementation step of that strategy. For an overview of this new National Pharma Strategy, we invite you to read our previous blog on this topic.

The Medical Research Act was first presented to stakeholders in late January 2024. For a comprehensive overview of this first draft, please see our earlier earlier blog. After an initial consultation, the Government revised the draft and initiated the legislative process at the end of May 2024. Overall, the Government has deployed an unusually fast pace and was successful with its plan to get the bill through Parliament before the summer break.Continue Reading Germany amends drug pricing and reimbursement laws with “Medical Research Act” – Drug pricing becomes intertwined with local clinical research expectations

In line with its previous decision-making practice (see our previous sustainability blog posts here and here), on 8 May 2024, the German Federal Cartel Office (“FCO”) declared the implementation of a new European industry standard for reusable pot plant trays compatible with competition law.

Since 2021, companies and associations…

Continue Reading FCO gives green light for ‘greener’ plant trays

This year’s Munich Security Conference reemphasized the need for Europe to invest in greater defense capabilities and foster a regulatory environment that is conducive to building a defense and technological industrial base. In Munich, President Ursula von der Leyen committed to appointing a European Commissioner for Defence, if she is reselected later this year by the European Council and European Parliament. And the EU is also due to publish shortly a new defense industrial strategy, mirroring in part, the first-ever U.S. National Defense Industrial Strategy (NDIS) released earlier this year by the Department of Defense.

The NDIS, in turn, recognizes the need for a strong defense industry in both the U.S. and the EU, as well as other allies and partners across the globe, in order to strengthen supply chain resilience and ensure the production and delivery of critical defense supplies. And global leaders generally see the imperative of working together over the long-term to advance integrated deterrence policies and to strengthen and modernize defense industrial base ecosystems. We will continue tracking these geopolitical trends, which are likely to persist regardless of electoral outcomes in Europe or the United States.

These developments across both sides of the Atlantic follow on a number of significant new funding streams in Europe over the past couple of years, for instance:

  • The 2021 revision of the European Defense Fund Regulation allocated €8 billion for common research and development projects, meant to be spent during the 2021-2027 multi-annual financial framework (MFF).
  • As a direct response to Ukraine’s request for assistance with the supply of 155 mm-caliber artillery rounds, the EU adopted the 2023 Act in Support of Ammunition Production (ASAP), with a €500 million fund to scale up production of ammunition and missiles.
  • Most recently, the EU adopted the 2023 European Defense Industry Reinforcement through Common Procurement Act (EDIRPA), introduced a joint procurement fund of €300 million to facilitate Member States’ collective acquisition of defense products.
  • The European Peace Facility (EPF), an off-budget instrument, with an overall financial ceiling exceeding €12 billion, is primarily destined toward procurement of military material and large-scale financing of weapon supplies to allied third countries (including €6.1 billion for Ukraine).

Continue Reading Insights from the Munich Security Conference: Towards an Expanding U.S.-EU Defense Taxonomy?

Germany’s hospital system is reported to be of high quality but is also very expensive by international standards. Hospitals and healthcare payers such as health insurances are exposed to increasing economic constraints. One particular point of criticism is, for example, the current system of Diagnosis Related Group (DRG)-based fees.

Patient treatments are compensated based on the DRGs which effectively leads to a lump-sum payment system per diagnosis (with certain exemptions). This system has pros and cons. As a downside, it is reported to create incentives for over-treatments to generate DRG-based fees per patient.

At the same time, many hospitals in Germany are at risk of closure and insolvency due to financial challenges. The German federal states have thus asked the federal government for financial support to finance the restructuring of the hospital system and prevent hospitals from bankruptcy.

German federal and state governments have been discussing an intended hospital reform for months. Provided that no additional money flows into the healthcare system, the principle for this reform is “outpatient care before inpatient care”. The financial volume incentive shall therefore be minimised and a concentration on larger hospitals and medical institutions shall optimise or at least improve the current structures and quality of medical care in Germany. This shall also be accompanied by a reduction of the general number of hospitals in Germany.

On 10 July 2023, the key objectives of the envisaged hospital reform plans (Eckpunktepapier: Krankenhausreform) have been agreed on: (1) Ensuring security of supply (in particular public responsibility for ensuring the provision of healthcare, so-called “Daseinsvorsorge”), (2) securing and increasing the quality of treatment, and (3) reducing bureaucracy. Particularly, this is to be reflected in the following key measures:Continue Reading Germany plans significant hospital reform with broad impact on life sciences companies

Two speeches by the EU Commission President, Ursula Von de Leyen in March and April 2023, set out the EU’s policy towards China. In late April, the UK Foreign Secretary set out the UK’s emerging strategy and on the same day earlier this month, a UK Government Committee released a report which heavily criticized the UK’s dealings with China and the German Government released its long-awaited (and much-redrafted) China Strategy. 

This blog looks at similarities between the three approaches and what conclusions we might draw about the implications.

EU China Strategy

The EU first labelled China a systemic rival in 2019.  Since then, the European Commission has promoted the idea of “de-risking” the bloc’s most sensitive economic sectors to limit their dependence on China.

In a powerful speech in March 2023 Commission President Ursula Von der Leyen set out the need for the EU to develop its China Strategy.  The new strategy was needed because of what she described as the hardening of China’s overall strategic posture, matched by human rights abuses at home and an increasingly assertive stance in Asia. She was careful to note that the EU’s position on China would depend on how China interacts with ‘Putin’s war’ and how China meets international human rights obligations.  President Von der Leyen labelled as deliberate Chinese policies of disinformation and economic and trade coercion, saying they were used to target ‘countries to ensure they comply and conform’.

The tone of President Von der Leyen’s speech was set against the EU’s assessment that a newly assertive China was moving from an era of ‘reform and opening’ to one of ‘security and control’ whose purpose was ‘a systemic change of the international order [to place] China at its centre’.  In her speech, The Commission President noted that ‘all companies in China…are…obliged … to assist state intelligence-gathering operations and to keep it secret’. President Von der Leyen concluded that Chinese focus on military, tech and economic security would increasingly trump the appeal of free markets and open trade.

However, President Von de Leyen made clear that the EU did not seek to ‘cut economic, societal, political or scientific ties’, but rather to ‘rebalance the relationship on the basis of transparency, predictability and reciprocity.’ Using language reminiscent of President Macron’s call for the EU to seek greater ‘strategic autonomy’, President Von der Leyen argued that the new relationship would require the EU’s economy and industry to be more competitive and resilient in the cyber and maritime, space and digital, defence, innovation, health, digital and clean-tech sectors. President Von der Leyen pointed to the Net-Zero Industry and the Critical Raw Materials Acts as examples of the EU’s determination to respond to Chinese domination of these critical sectors.Continue Reading China and Europe: De-Risking the Relationship

On October 26, 2022, the German government permitted (with conditions) an investment by Chinese state-owned COSCO Shipping Group (“COSCO”) in one of Hamburg’s four shipping container terminals. Pursuant to foreign direct investment (“FDI”) laws, the German Ministry for Economic Affairs and Climate Action (Bundesministerium für Wirtschaft und Klimaschutz, “BMWK”) had been notified of the proposed acquisition by COSCO of a 35% minority interest in the port terminal, a strategic location on the German coastline. The BMWK ordered that COSCO’s acquisition of voting rights must remain below 25%. The details of the decision remain confidential, but the BMWK justified its partial prohibition on the grounds that the acquisition of 35% as notified would constitute a “threat to public order and security”. According to the BMWK’s press release, the partial prohibition decision prevents COSCO from acquiring a ‘strategic’ shareholding, and reduces the acquisition to a mere financial participation. As a safeguard in this respect, the decision contains provisions prohibiting COSCO from acquiring any additional influence, for example, through a grant of rights that would be atypical for a holder of a less than 25% interest. Furthermore, under the German FDI regime, any follow-on acquisition of additional voting rights by COSCO would be subject to a new notification requirement.

Facts and Background

According to public sources, the transaction has been highly debated within and outside Germany since the announcement of the transaction in September 2021. Parties closely related to the commercial development of the Hamburg port (including the selling Hamburg port operator, the current mayor of the city of Hamburg, and the trade union) favoured an unconditional approval pointing to the economic significance of the investment. But a number of stakeholders, including apparently the European Commission, which provided an opinion within the framework of the EU FDI Regulation, would have preferred an outright prohibition of the transaction.Continue Reading COSCO FDI Review: Germany partially prohibits Chinese investment in a Hamburg container terminal – Spotlight on minority investments

Germany_Flag_2400x1260

Following the federal election in September 2021, Germany will soon be led by a new three-party coalition, the so-called “traffic light coalition”, composed of the Social Democratic Party (SPD), the Liberal Democrats (FDP) and the Green Party (Die Grünen). This new federal government…
Continue Reading New German Government plans significant changes with Impact on the Healthcare, Life Sciences and Food Sector