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 who design and develop AI-embedded
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.
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.
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 will then set out the
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 the potential to enhance every
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 Agency (“MHRA”) on the implementation
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 is “focused on providing
The Voluntary scheme for branded medicines pricing and access (“VPAS”) is a voluntary agreement that regulates the price of the vast majority of branded medicines sold in the UK (including branded generics and biosimilars). VPAS is critical to the commercial interests of most innovative pharmaceutical companies operating in the UK. It has traditionally
On April 27, 2023 the European Commission (“Commission”) released its proposal to introduce a single procedure for the granting of Supplementary Protection Certificates (“SPCs”) throughout the EU. The changes are intended to complement the new unitary patent procedure that will enter into force on June 1, 2023. The Commission intends the new unitary SPC to
Borderline issues arise when the regulatory classification of a product, for example, as a medicine, a medical device or a food supplement, is unclear. Uncertainty about the regulatory status of a product under development, and consequently uncertainty as to what legal rules need to be followed, can have immense consequences for developers and innovators. To