Libby Amos-Stone

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On 27 February 2023, an agreement in principle was reached by the UK and EU, known as the Windsor Agreement, relating to post-Brexit trade issues in Northern Ireland (NI). The principles are expected to be approved shortly by the EU-UK Joint Committee. The UK Government and the EU institutions will then enact legislative measures to make the necessary amendments to their laws. 

Following Brexit, from 31 January 2020, the UK is no longer subject to EU single-market rules or the EU legislative framework. However, under the EU-UK Withdrawal Agreement’s Protocol on Ireland and Northern Ireland, NI continues to follow EU rules. This is to avoid customs checks between NI and the Republic of Ireland. In practice, this means that medicinal products on the market in NI must be authorised in line with the EU regime, which no longer applies in Great Britain. This causes difficulties for companies marketing their products in the UK, as different authorisations, following different rules, apply in different parts of the UK. It also means that patients have access to different products in GB or NI.

The current agreement covers a number of sectors, and in relation to medicines, the aim is to simplify supply between GB and NI, and ensure that only one authorisation is needed and one set of rules needs to be followed within the UK. However, much detail still needs to be published so that companies can fully understand the impact of the changes on their medicines supply chains.Continue Reading The Windsor Agreement and supply of medicinal products in Northern Ireland

On 26 January 2023, the Prescription Medicines Code of Practice Authority (the PMCPA) published long-awaited Guidance on Social Media 2023 (the Guidance). While a Digital Guidance note, which covered certain issues arising from use of social media, was published by PMCPA in 2016, the large number of complaints since that time is evidence of continued uncertainty regarding permitted activity in this area.    

However, while the Guidance acknowledges the challenges introduced by the “open and transitory” nature of social media, it broadly reflects recent PMCPA decisions and rejects the more permissive approach that some stakeholders had advocated was appropriate.  Nevertheless, the additional clarity provided by the Guidance is welcome and, by defining general principles applicable to use of social media and issuing more detailed guidance in certain areas, PMCPA has provided a framework to assist companies in managing their social media activity going forward. Continue Reading UK PMCPA publishes long-awaited guidance on use of social media

Synopsis

On 22 September 2022, the UK government introduced the Retained EU Law (Revocation and Reform) Bill 2022 (the ‘Bill’) to Parliament. The Bill provides a mechanism to remove EU law currently on the national statute book and transition towards only domestically enacted legislation. A revised Bill was published on 29 November 2022 following its first debate in parliament and scrutiny by the Public Bar Committee. If current timelines are maintained, it is anticipated that the Bill would be passed in April or May 2023.
Continue Reading The Retained EU Law (Revocation and Reform) Bill 2022 – key facts and issues

The international and European self-regulatory bodies for the research-based pharmaceutical industry (IFPMA, International Federation of Pharmaceutical Manufacturers and Associations and EFPIA, European Federation of Pharmaceutical Industries and Associations) yesterday published a Note for Guidance to assist member companies with their use of social media and digital channels.

In the EU and UK, direct to consumer (DTC) promotion of prescription only medicines (POMs) is prohibited. Given the reach of social media, the Guidance correctly identifies the highest risk for companies as unauthorised promotion of POMs to the public. In addition, it notes that information shared through digital channels that can be accessed globally generates risk and uncertainty for industry. These risks, combined with the difficulty of controlling the content and audience of posts (both geographically and due to the prevalent use of social media by employees and affiliated third parties), have resulted in many companies being found in breach of self-regulatory codes.

The Guidance aims to set out the areas that companies should consider when communicating on social media and other digital channels, and builds on existing guidance, including the Principles for the use of digital channels in the EFPIA Code. IFPMA and EFPIA intend the Guidance to act as an “evolving resource”. This is welcome; uses of social media are continually expanding and it has been difficult for industry to apply pre-social media legislation and guidance to the modern world. It would be helpful if local self-regulatory authorities provide their own (or update previous) guidance in line with the new Guidance to ensure it is appropriately implemented within the national Codes.Continue Reading ATTENTION SOCIAL MEDIA USERS: New IFPMA and EFPIA Guidance on use of social media by industry

The VPAS Payment Percentage for 2023, including the adjustments for accumulated Under Payments, is expected to be in excess of 26%.  As such, a number of VPAS Members have indicated that they are considering moving from VPAS to the Statutory Scheme. We explore how the situation arose and the implications below.
Continue Reading Concern over high Scheme Payments under the UK VPAS

On 31 March 2022, the Food Standards Agency (FSA) published the list of cannabinoid (CBD) containing food products that have a credible application for novel food authorisation pending with the FSA.

The products on the list may remain on the market in England and Wales while their application is considered.  For CBD products not on the list, FSA advises local authorities to encourage marketers to voluntarily remove their products from the market to avoid more formal action.
Continue Reading Important Milestone for CBD Products in England and Wales

As we have previously reported, under the Northern Ireland Protocol of the Withdrawal Agreement between the EU and UK, Northern Ireland (“NI”) has continued to follow the EU rules after the end of the transitional period. In contrast, Great Britain (“GB”) now has a freestanding independent regulatory regime. This means that there are two sets of rules that apply in the UK, and this has led to difficulties with medicines, and other products, moving from GB to NI (the route by which the majority of products reach the market in NI).

In December 2020, the European Commission published a notice that allowed certain flexibilities to be in place through 2021 to ensure there were no medicine shortages in NI (as well as other territories historically dependent on medicines supply through GB). As 2021 concluded, industry – and patients – had been concerned that no long-term solution had been found.

After protracted negotiations, on 17 December 2021, the European Commission put forward proposals to ensure the continued undisrupted supply of medicines from GB to NI. The proposals seek to ensure that patients in NI will have access to life-saving medicines at the same time as patients in the rest of the UK. These proposals also allow time to put in place long-term solutions for the supply of products to NI, and time for industry to adapt to future regulatory requirements and changes.

In parallel, legislation changes have been made in the UK, and the MHRA guidance has been, and is being, updated to reflect the proposals, although they are not yet formally adopted by the EU legislative bodies. Further, the MHRA has stated that there is a reporting obligation on industry to notify the MHRA if the flexibilities applicable to NI will not be used.Continue Reading Brexit update: Supply of Medicines from Great Britain to Northern Ireland

We discussed in previous posts the Commission’s announcement at the end of 2020 of its new pharmaceutical strategy for the EU. One topic identified as in need of revision was the unmet medical needs in areas currently not within the scope of the legislation governing rare diseases and paediatric medicines.  We have previously discussed recent consultations and stakeholder engagements by the Commission to explore possible changes to the legislative regime in these areas, including the possibility of reducing the ten-year market exclusivity period for orphan medicines and changing the criteria for determining the rarity of a disease.

Following the responses to these consultations, in May 2021, the Commission launched its latest public Consultation on the proposed revisions to the legislation.  The Commission’s statement accompanying the launch asserts that its evaluation “revealed shortcomings in the current system concerning in particular the development of medicines in areas of high unmet need for patients and their accessibility to all EU patients across the Member States.” Industry bodies representing the innovative pharmaceutical industry have now published their responses to the Consultation, as summarised below.
Continue Reading Industry’s response to the Commission’s proposed amendments to the EU orphan and paediatric legislation

On 20 October 2020, “The Human Medicines (Amendment etc) (EU Exit) Regulations 2020” Bill was laid before the UK Parliament (the 2020 Bill). The Bill proposes amendments to various Statutory Instruments that were drafted in 2019 (the 2019 SIs) in anticipation of a “no-deal” Brexit. The 2019 SIs sought to enable the pharmaceutical regime in the UK to function independently of the EU, and for the MHRA to act as a stand-alone regulator of medicinal products placed on the UK market. The 2019 SIs have now been revived so that they are effective beyond the end of the transition period, which expires on 31 December 2020, subject to any agreement that may be reached with the EU about the ongoing relationship between the UK and EU.

The 2020 Bill includes a number of changes to the 2019 SIs, which themselves changed the current Human Medicines Regulations of 2012. However, one area that is of particular interest to the industry is the regulatory data protection (RDP), marketing protection and orphan exclusivity periods that apply to medicinal products authorised in the UK after the transition period. The 2020 Bill changes the position that had previously been set out in the 2019 SIs.
Continue Reading RDP periods in the UK after Brexit