UK

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)

Roughly a decade ago, countries such as the USA and France introduced ground-breaking transparency and disclosure legislation under so-called “Sunshine Acts.”  Broadly speaking, such legislation made it mandatory for pharmaceutical companies to publish records of payments or other transfers of value made to healthcare professionals (HCPs) and healthcare organizations (HCOs).

The UK followed a subtly…

On 29 September 2023, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published further guidance (“MHRA Guidance”) on changes to labelling and packaging for medicinal products intended for the UK market (including Northern Ireland) under the Windsor Framework (agreed between the UK and the EU on 27 February 2023, please see our client alert here). 

The MHRA Guidance follows the Agency’s announcement of new labelling and packaging measures in June 2023, which will take effect from 1 January 2025.  The new measures require, amongst other things: (i) medicinal products intended for the UK market to be authorized by the MHRA; (ii) a single UK-wide pack that bears a “UK only” label; and (iii) disapplication of the EU Falsified Medicines Directive 2011/62/EU (“EU FMD”) to UK packs (please see our blog post on this announcement here).

The latest MHRA Guidance provides further detail on the above measures.…

Continue Reading New MHRA Guidance on the Windsor Framework: Detail on Labelling and Packaging Changes

On 30 August 2023, the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) published detailed guidance on its recently announced new International Reliance Procedure (“IRP”) (see our prior blog and audiocast).  The IRP will apply from 1 January 2024 and will replace and significantly expand on existing EU reliance procedures to apply to authorizations…

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)

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 21 March 2023, the UK Government published its response to the consultation on legislative reform proposals for clinical trials that took place from January to March 2022. 

The current legislation governing clinical trials in the UK is the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended.  This implements the EU Clinical Trials Directive 2001/20/EC and has not been amended to align with the subsequently introduced EU Clinical Trials Regulation 536/2014.

The proposed reforms centre on delivering “a more agile and flexible UK regulatory framework”, as part of the Government’s broader ambition to create a more appealing regulatory environment for life sciences innovation in the UK.  The emphasis on promoting clinical research in the UK was highlighted by the recent Government announcement of an independent review into UK clinical trials, prompted by figures suggesting that the number of industry clinical trials initiated in the UK per year fell by 41% between 2017 and 2021.  In addition, a decline in public engagement with clinical research (with a 44% drop in the number of participants recruited to commercial clinical trials in the last five years) highlights the need for reform in this area.

The Government’s proposed reforms involve streamlining the procedures supporting the approval and conduct of clinical trials, removing duplicative requirements, and enabling flexibility in a risk-based and proportionate manner. 

The proposals also envisage a clinical trials regime that requires greater transparency and encourages, though notably will not require, a diverse range of patient and public involvement.

The main proposals with which the Government intends to move forward are discussed below.…

Continue Reading Legislative Proposals for Clinical Trials Aim to Streamline, Simplify and Stimulate UK-based Innovation

To avoid a real and imminent risk of shortages of devices on the EU market, the European Commission recently adopted Regulation (EU) 2023/607, extending the transitional provisions in Regulation (EU) 2017/745 (the “MDR”) and removing the sell-off period in the MDR and Regulation (EU) 2017/746 (the “IVDR”). The Commission has published a Q&A on the practical aspects of the latest changes (the “Q&A”). We set out the top 10 questions to think about when assessing how the changes to the MDR and IVDR may impact you and your medical devices.
Continue Reading How do the recent changes to the MDR and IVDR impact you and your medical devices?  — Top 10 Questions