Access to Medicines

EU

  • The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published three reports, which show the inequalities in the time it takes for European patients to access medicines. The reports highlight that patients in one European country can wait more than six times as long as patients in another country for the same medicines. For further information and links to the reports see here . The Association of the British Pharmaceutical Industry (ABPI) has also issued a press release highlighting the position across England, Scotland and Wales.

Artificial Intelligence

UK

  • The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on Software and artificial intelligence (AI) as a medical device to include reference to guiding principles on transparency for machine learning-enabled medical devices. See updated Guidance for further information.

Clinical Trials

EU

  • The Accelerating Clinical Trials in the EU (ACT) collaboration has launched two new initiatives to improve clinical trials in Europe. The first pilot offers developers of medicinal products scientific advice on clinical trials and on requirements for marketing authorisation applications. The second pilot is coordinated by the Clinical Trials Coordination Group (CTCG) and provides technical and regulatory support on the dossier of a clinical trial application prior to its submission through the Clinical Trials Information System. See European Medicines Agency press release for further information.

Switzerland

  • Switzerland has adopted changes to its human research and clinical trial regulations. The aim of the amendments is to strengthen the protection of individuals participating in research and improve the regulatory framework for researchers. For further information on the changes see Swissmedic press release here

Code of Practice

UK

  • The Prescription Medicines Code of Practice Authority (PMCPA) has issued an update regarding the proposed changes to the 2021 Code of Practice, following its consultation, which closed at the end of February. The PMCPA has confirmed it aims to agree the text of the new Code in July 2024, with approval in September 2024. See PMCPA press release for further information.

Competition Law

EU

  • The European Commission has sent its Statement of Objections to Alchem International Pvt. Ltd. and its subsidiary Alchem International (H.K.) Limited (Alchem) with its preliminary view that they have breached EU antitrust rules by participating in a long-lasting cartel concerning the pharmaceutical product N-Butylbromide Scopolamine/Hyoscine (SNBB). Alchem is a producer of SNBB. The Commission has expressed concerns that Alchem may have coordinated and agreed with other market participants to fix the minimum sales price of SNBB to customers and to allocate quotas. See European Commission Press Release for further information.

Italy

  • The Italian competition authority, (Autorità Garante della Concorrenza e del Mercato) has launched an investigation against eight pharmaceutical companies over suspicion they may have colluded to delay the launch of biosimilar versions of the eye drug Lucentis. See press release for further information.

Data Privacy

EU

Health Technology Assessment

Nordics

  • A joint Nordic HTA collaboration has expanded to boost joint assessments. Information on the new Joint Nordic HTA bodies collaboration can be found here

Medical Devices

UK

  • The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance for transparency for machine learning-enabled medical devices. The transparency principles align with previously published guiding principles and offer good practice guidelines on transparency for all medical devices. See guidance

Regulatory

EU

  • The European Medicines Agency Human Medicines Highlights Newsletter for May 2024, including information on CHMP opinions and new medicines is available here

Substances of Human Origin

EU

  • On 27th May 2024 the European Council adopted the new Regulation on standards of quality and safety for substances of human origin intended for human application. For further information see press release

Sustainability

EU

EFPIA has issued a statement on the pharmaceutical sector’s environmental sustainability commitments. See press release for further inform

For further information on these developments and how it could affect business, please contact us, we are always happy to provide our insights.

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