Tune into this episode of Covington’s Life Sciences Audiocast, where Winsome Cheung and George Jenkins discuss the key trends in Life Sciences Transactions for 2024. The speakers discuss the outlook for deal-making in Life Sciences and predictions for deal trends, including in relation to nuclear medicine, GLP-1, antibody-drug conjugates and other modalities. The speakers also
EU Health Emergency Mechanisms: Impact on Medical Devices
The European Union has adopted various new rules for emergency situations relating to public health. These new measures build on the experience gained from the COVID-19 pandemic and give new powers to the European Commission, in close cooperation with the Member States.
The new rules create a complex public health crisis management system. Measures that
Germany again to reform drug pricing and reimbursement laws – With “confidential reimbursements prices” that impede international reference pricing
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 January 2024, the German government
Germany 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 clinical trials, GMP issues for
EMA announces €10 million of funding to support the establishment of the African Medicines Agency
On 26 January 2024, the European Medicines Agency (EMA) announced that it has received a €10 million grant from the European Commission to support regulatory systems in Africa, and in particular for the setting up of the African Medicines Agency (AMA). Although still in its early stages as an agency, AMA shows significant promise to
EU Adopts New Rules on Greenwashing and Social Impact Claims
On January 17, 2024, the European Parliament formally endorsed its provisional agreement with the Council on the Directive Empowering Consumers for the Green Transition through Better Protection against Unfair Practices and Better Information (“Greenwashing Directive”). The Council is now expected to endorse the provisional agreement after which the Directive will be published in
Single Market Emergency Instrument: Potential Impact on Medical Devices
The European Parliament and Council are currently negotiating the wording of a new Regulation establishing a Single Market emergency instrument (“SMEI”). This new measure builds on the experience gained from the COVID-19 crisis and gives new powers to the Commission, in close cooperation with the Member States. This blog briefly discusses the expected impact on
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
EU Talking Life Sciences Audiocast: Major Changes to the UK’s Price Control Schemes for Branded Medicines – VPAG and the New Statutory Scheme – What You Need to Know
Recently announced changes to the Voluntary Scheme (VPAG) and Statutory Scheme change the paradigm for the pricing of branded medicines in the UK. Innovative pharmaceutical companies doing business in the UK must decide which scheme to join for 2024 – a decision that may significantly affect margins.
Tune into this episode of Covington’s Life Sciences
VPAG – New 5-Year Pricing Agreement Agreed between UK Government and the UK Pharmaceutical Industry Body (ABPI)
On 20 November 2023, the UK Government and the Association of the British Pharmaceutical Industry (“ABPI”) ‒ the industry body representing the innovative pharmaceutical industry in the UK ‒ announced a new 5-year voluntary scheme for branded medicines pricing, access and growth (“VPAG”).
Although the parties have announced agreement upon heads of terms, it is already clear this is very significant news for the pricing and reimbursement of branded medicines in the UK. It is likely to represent a paradigm-shift in the way the innovative pharmaceutical industry will view reimbursement.Continue Reading VPAG – New 5-Year Pricing Agreement Agreed between UK Government and the UK Pharmaceutical Industry Body (ABPI)