Medicinal Products

Hot off the press, yesterday evening, 29 September 2026, the German Government’s expert committee presented the eagerly awaited proposal for a new “location clause” (Standortklausel) to incentivize pharmaceutical R&D and manufacturing in Germany. Under this proposal, pharmaceutical companies can apply for a reduction or complete waiver of the…

Continue Reading Germany Reviews a New Pharma “Location Clause” (Standortklausel) for Pricing & Reimbursement Incentives – Improvement or Worsening for the Pharmaceutical Industry?

Tomorrow, on 30 July 2026, the “GKV-Beitragssatzstabilisierungsgesetz” (GKV-BStabG) will enter into force, marking the culmination of a fast-paced and politically contentious legislative process. The reform, which has attracted significant attention, introduces a broad package of cost-containment measures across the statutory health insurance (GKV) system. Several of these specifically target pharmaceutical…

Continue Reading What does the GKV-BStabG Reform Change for Pharma Pricing & Reimbursement in Germany? And the Reforms Are Not Over: What to Expect From the New German Minister of Health and the Pharma Dialogue?

On 2 April 2026, the UK Government published text memorializing its agreement with the U.S. in relation to pharmaceutical pricing.  The UK now refers to this as an “arrangement” (“U.S.-UK Pharmaceutical Pricing Arrangement”).  Our blog post from December discussed the in-principle heads of terms for the deal announced…

Continue Reading U.S.–UK Pharmaceutical Pricing Agreement: Learnings from the Published Text

I. Background – From Pharma-Dialogue to Compulsory Price Cuts

Tomorrow, on 29 April 2026, the German Government is expected to adopt a new law to stabilize the finances of the statutory health insurances. This draft law titled “GKV-Beitragssatzstabilisierungsgesetz” (GKV-BStabG) proposes manifold cost-containment measures that would also significantly impact pharmaceutical companies.

Continue Reading Germany plans significant cuts in drug pricing and reimbursement – How would the GKV-Beitragssatzstabilisierungsgesetz impact pharmaceutical companies?

Germany has kicked off a new Pharma and MedTech Dialogue that aims to develop new policies and regulatory reform proposals to re‑establish Germany as a competitive, innovation‑friendly location for life sciences R&D and manufacturing. The outcome of this dialogue shall be the basis for a new German Pharma and MedTech…

Continue Reading German Government launches new Pharma & MedTech Dialogue – Broad agenda, big hopes but unclear prospects

In a landmark judgement, the Higher Regional Court of Cologne has set new standards for pharmaceutical advertising with influencers. First, a key point from the decision is that the court qualifies paid influencers as agents of the drug company with respective consequences for the company (discussed below). Second…

Continue Reading Influencer Marketing – German court sets new Guardrails for Pharmaceutical Advertising on Social Media

On 1 December 2025, the UK Government announced a “landmark” UK-US pharmaceutical deal.   Under the deal, the UK claims to be (so far) the only country to secure zero-percent tariffs on pharmaceuticals exported to the US for the next three years.  In return, the UK has committed to increase its…

Continue Reading Landmark UK-US Pharmaceutical Deal

Germany has taken another step to improve the conditions for pharmaceutical research & development in Germany. Now, the Federal Government has adopted the “Standard Contractual Clauses” for pharmaceutical clinical trial agreements. In this blog, we discuss what the new standard clauses cover and how they will affect clinical trials in…

Continue Reading Germany enacts Standard Contractual Clauses for pharmaceutical clinical trial agreements – Changes for medical device studies also on the horizon

Image Credit: World Health Organization

On 16 April 2025, Member States of the World Health Organization (WHO) concluded negotiations on a new international treaty: the Agreement on pandemic prevention, preparedness and response (“WHO Pandemic Agreement”). Set to be adopted at the May 2025 World Health Assembly, this landmark accord aims…

Continue Reading What Companies Should Know About the WHO Pandemic Agreement

The joint procurement by the European Commission (“Commission”) and the Member States of COVID-19 vaccines and therapeutics presented a significant milestone in the EU’s management of the pandemic.  In the aftermath of the pandemic, there have been repeated calls for more joint procurement.  This blog explores the existing mechanisms for joint procurement and also considers the Commission’s proposal for a Critical Medicines Act (“CMA”) and what it would mean for public procurement.

At a high level, there are already various mechanisms for joint procurement of medicinal products and medical devices both with and without involvement of the Commission.  The CMA proposal does not fundamentally change that but rather supplements the existing regimes.

The key aspect to be aware of is that both the existing regime and the draft CMA merely establish a framework for joint procurement, including the relationship among Member States and the Commission (if involved).  This framework focusses on establishing when joint procurement is possible and the mechanism for getting a joint procurement set up.  However, the framework does not specify in what circumstances Member States and/or the Commission might choose to engage in joint procurement, the terms of the tender or any resulting contract.

Continue Reading EU Joint Procurement – An Overview