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Pharmaceuticals & Biotech

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Baker McKenzie partner Aarthi Belani, AbbVie head of immunology business development and acquisitions Rachel Strick, Flare Capital Partners co-founder Michael Greeley and Patient Square Capital founding partner Neel Varshney share their insights on M&A trends in the healthtech and biotech sectors for the third episode of the Talking M&A podcast. 🔊 Talking M&A Episode 3 – Spotlight on healthtech and biotech in partnership with #BakerMcKenzie, is available to listen to here: http://spr.ly/60473clHl 16 minute listen…

In brief Starting from 31 January 2023, the Clinical Trial Information System (CTIS), provided for in Art. 80 of Regulation EU 536/2014, will become the single point of access for the submission, authorization and supervision of clinical trial applications in the EU and the European Economic Area (EEA) countries. Key takeaways The single portal was launched on 31 January 2022, initiating the one-year transition period during which sponsors could choose whether to submit a clinical…

In Brief 2023 is gearing up to be an interesting year for those in the life sciences sector, with upcoming reforms to the established regulatory and IP landscapes that will impact innovator strategies in R&D, commercialisation, and patent enforcement. While reforms are currently under draft by the European Commission, the key areas of anticipated change are highlighted in a newly published article in The Life Sciences Lawyer. “EU reforms in the pharmaceutical sector – a…

In brief The first ever guidance on social media has been issued by the Prescription Medicines Code of Practice Authority (PMCPA) to help pharmaceutical companies apply the high standards demanded by the industry’s ABPI Code of Practice to all their online communications channels. The PMCPA Social Media Guidance 2023 has been produced in consultation with the Medicines and Healthcare Products Regulatory Agency (MHRA), the ABPI, and pharmaceutical companies. It includes advice for companies to help them use…

In brief The MHRA lifted some extra burden from the industry by extending the European Commission Decision Reliance Procedure (ECDRP) by 12 months until 31 December 2023. The ECDRP was introduced following Brexit and is available to medicines approved via the EU centralized procedure. Before 31 December 2023, in situations where a Committee for Medicinal Products for Human Use (CHMP) positive opinion has been received, applicants can continue to submit their ECDRP Marketing Authorisation Application (MAA) or…

In brief A new EU-level recommendation paper (“Paper”) sets out wide-ranging recommendations for sponsors of decentralized clinical trials (DCTs). The Paper is great news for sponsors facing an array of grey areas and gaps in regulatory guidance around DCTs. It provides guidance on common issues in designing and implementing DCTs: from documenting the delegation of tasks to digital service providers, to obtaining e-consents and how investigators should manage new streams of incoming data. The recommendations…

The UK’s Department of Health and Social Care has announced that the voluntary scheme payment percentage (VPAS) for 2023 will be set at 26.5% of sales for 2023 (representing almost GBP 3.3 billion). This is a further major increase to last year’s VPAS significant rate rise to 15% (around GBP 1.8 billion, rising from GBP 0.6 billion in 2021). VPAS is an agreement between the Department of Health and Social Care (DHSC), NHS England and…

The European Court of Justice (the “Court”) has upheld the lawfulness of a Latvian law banning any advertising of medicinal products to the general public that encourages purchases by offering discounts and other special price offers, including reduced bundled pricing. The Court goes as far as saying that Member States must ban such advertising, even if not expressly prohibited by EU harmonising rules, where that is necessary to prevent the irrational use of medicines that…

In brief On 10 November 2022, the National Coordination Centre for Ethics Committees (“Centre”) published the updated versions of the “Contract for the performance of clinical trials on medicines,” the “Contract for the performance of independent clinical trials on medicines” and the “Contract for the performance of clinical investigations on medical devices that are not CE marked or CE marked but used outside their intended use.” Key takeaways In particular, the updates relate to: (i)…

Ukraine has adopted the new law on pharmaceuticals (“Law”) that fundamentally changes the regulatory framework for pharmaceuticals. The Law is largely based on EU laws, although certain provisions, including as regards parallel importation of pharmaceuticals and regulatory data protection, are not aligned with EU laws and may create hurdles for companies operating in the Ukrainian market. The Law will be enacted within 2.5 years after the expiry/lifting of martial law. In this video, we present these and…