In an earlier blog, we wrote that the German regulation of pharmaceutical pricing and reimbursement is one of the most complicated legal areas in the entire world of life sciences laws. With the new draft “Medical Research Act” (Medizinforschungsgesetz or MFG) that came out in
Continue Reading Germany again to reform drug pricing and reimbursement laws – With “confidential reimbursements prices” that impede international reference pricingGermany will revise laws for clinical trials with pharmaceuticals, medical devices and companion diagnostics – Overview of the “Medical Research Act”
Significant changes are on the horizon for clinical trials in Germany. At the end of January 2024, the German Federal Health Ministry has presented the draft for a “Medical Research Act” (Medizinforschungsgesetz or MFG). The draft bill proposes legislative amendments in several areas that span from
Continue Reading Germany will revise laws for clinical trials with pharmaceuticals, medical devices and companion diagnostics – Overview of the “Medical Research Act”
Consultation on Changes to the ABPI Code and UK Advertising Complaints Process
The Holiday season of 2023 proved to be a busy one for innovative pharmaceutical companies in the UK and their legal and regulatory teams.
UK pharmaceutical companies are already number-crunching through two new price control systems for 2024 (please see our blog and audiocast). In addition to the UK pricing regime changing, there are proposals to update advertising rules and the procedure for adjudicating upon advertising complaints.
On 13 December 2023, the Association of the British Pharmaceutical Industry (“ABPI”) published proposals to update the 2021 ABPI Code of Practice for the Pharmaceutical Industry (“ABPI Code”) and the Prescription Medicines Code of Practice Authority (“PMCPA”) Constitution and Procedure (which sets out the procedure for adjudicating upon advertising complaints). Companies have until 29 February 2024 to contribute to the consultation.
Many of the proposed changes to the ABPI Code are clarificatory in nature, but the planned changes to the complaints process may be of particular interest to in-house legal teams. These changes are designed to make the PMCPA complaints process less formulaic and more flexible. This could help manage relatively straightforward cases with greater efficiency, whilst also accommodating for cases which involve serious allegations and/or complex facts. If implemented as proposed, the changes are likely to give PMCPA cases a more judicial or legalistic feel, particularly when it comes to case management.Continue Reading Consultation on Changes to the ABPI Code and UK Advertising Complaints Process
WHO Publishes Regulatory Considerations on AI for Health
On October 19, 2023, the World Health Organization (“WHO”) published a set of regulatory considerations on artificial intelligence (“AI”) for health (press release and full publication). The publication is not guidance or policy but is intended as a resource for relevant stakeholders in medical devices ecosystems, including manufacturers
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UK Government to Recognize CE Marks Indefinitely (other than for Medical Devices and IVDs)
Big news for manufacturers: the UK Government announced on 1 August 2023 that it will indefinitely recognize the EU’s product conformity assessment mark (the “Conformité Européenne” or “CE” mark), with respect to a range of manufactured goods placed on the UK market.
The move is a significant reversal of the UK’s previous, post‑Brexit policy. In a bid to separate the UK’s internal market from the European market, the UK promised to phase out CE marks for products marketed in England, Scotland and Wales (Great Britain or “GB”), and replace them with an equivalent “UKCA” mark. However, the project suffered from numerous delays, and the UK repeatedly extended the deadline for transitioning from the CE mark to the UKCA mark, before the recent announcement that the UK will accept CE marks indefinitely. Despite this change of policy, the UK has not abandoned the UKCA mark yet, and manufacturers may still choose to use it. Even so, it is not obvious why a manufacturer would choose conformity assessment that is recognized only in the UK over (or even as well as) conformity assessment that is recognized across the UK and the EU. What remains to be seen is whether differences between the UK and EU conformity assessment standards will lead to a kind of “forum shopping” by manufacturers.
Also, and of significant importance for medical device manufacturers, the indefinite extension of CE mark recognition does not (at least currently) cover medical devices nor in vitro diagnostic medical devices (“IVDs”). The Medicines and Healthcare products Regulatory Agency (“MHRA”) is separately consulting on international recognition of foreign approvals (including CE marks) in the medical device space.Continue Reading UK Government to Recognize CE Marks Indefinitely (other than for Medical Devices and IVDs)
Germany plans significant hospital reform with broad impact on life sciences companies
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.Continue Reading Germany plans significant hospital reform with broad impact on life sciences companies
EU Talking Life Sciences Audiocast: The UK’s Medicinal Product and Medical Device Reliance Routes
Tune into this episode of Covington’s Life Sciences Audiocast, where Grant Castle, Marie Doyle Rossi, and Ellie Handy discuss the UK’s recent announcement of new international reliance routes for medicinal products and medical devices. The speakers will discuss existing EU reliance procedures offered by the UK. They
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EMA Releases Reflection Paper on AI/ML in the Medicinal Product Lifecycle
Hot on the heels of recent announcements from the U.S. Food and Drug Administration (see our prior blogs here), the European Medicines Agency (“EMA”) has joined the conversation on the use of Artificial Intelligence (“AI”) and Machine Learning (“ML”) technologies in the medicinal product lifecycle.
AI and ML have
Continue Reading EMA Releases Reflection Paper on AI/ML in the Medicinal Product Lifecycle
New MHRA Guidance on the Windsor Framework: Timings Confirmed but More Details to Follow
On 9 June 2023, the UK Government published further guidance relating to the practical implementation of the Windsor Framework (agreed between the UK and the EU on 27 February 2023, please see our client alert here). This overarching guidance contains further detail from the Medicines and Healthcare products Regulatory
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Fast-Tracking Access to New Medicines – UK Announces New International Reliance Route
On 26 May 2023 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced it plans to introduce an international reliance route for the approval of medicinal products. This shows the UK is now looking beyond the EU in its approach to recognizing foreign marketing authorizations. The MHRA
Continue Reading Fast-Tracking Access to New Medicines – UK Announces New International Reliance Route