The European Commission (“Commission”) intends to change the rules on regulatory data protection (“RDP”) of medicinal products. The Commission stated in its Impact Assessment for the revised pharmaceutical legislation that it wants to strike a balance between “providing attractive incentives for innovation and supporting timely patient access to medicinal
Continue Reading EU Pharma Legislation Review Series: Regulatory Data Protection
This is the first in a series of Covington blogs about the EU’s proposals to amend the current pharmaceutical regulatory framework, which were released today (see here). It introduces some of the key aims and themes and invites readers to read more in-depth summaries as we release them.
Continue Reading EU Pharma Legislation Review Series: The EU’s proposals to amend its pharmaceutical laws released today
The relationship between the UK and the Republic of Ireland (ROI) came into sharp focus recently, as US President Joe Biden visited ROI. Biden’s visit coincided with the 25th anniversary of the Belfast (Good Friday) Agreement 1998 (GFA) which brought an end to 30 years of Troubles in Northern Ireland (NI). The UK government will have welcomed the fact that President Biden described the Windsor Framework (WF) as one of two pillars (along with the GFA) which are key to future peace and prosperity in NI. The WF is also fundamental to the recent improvement of the tripartite UK-EU-ROI relationship.
The Northern Ireland Protocol (NIP) was part of the UK’s withdrawal from the EU and sought to square the circle of respecting the GFA, whilst maintaining NI’s place in the UK Single Market. But the Unionist community in NI felt the NIP left NI being treated differently from the rest of the UK – a feeling which led to the 2022 suspension of the Stormont Assembly. The negotiation of the WF demonstrated a new and welcome willingness of the UK and the EU to negotiate mutually acceptable solutions to some of the problems created by Brexit (even if the WF has not (so far) achieved one of its objectives of re‑starting power-sharing at Stormont).
What has Changed under the WF?Continue Reading The Implications of the Windsor Framework
Those in the business of fast‑moving consumer goods (“FMCGs”) are likely aware of the plethora of environmental and product stewardship regulations applicable to the FMCG sector. These laws are set to increase and expand in application. What FMCG companies also need to get to grips with are a range of broader (and also fast‑moving!) environmental, social and governance (“ESG”) developments and consequent risks and opportunities. Companies need to understand how the new world of ESG impacts their supply chains, key ingredients and components, consumer choice and confidence, competitive advantage, market accessibility, and marketing.
Designed as a ‘primer’ for FMCG companies, in this piece, we cover a range of key trends in the emerging UK and EU ESG legal landscape as relevant for the FMCG sector, from farmers to Food Business Operators (“FBOs”) and from manufacturers to retailers. We also discuss some key legal and reputational risks; as well as pointers to help companies decipher and prepare for the ESG storm.
We focus on the UK and the EU (first movers on many ESG issues), but the landscape in other jurisdictions (including, for example, the US) is also evolving and becoming more complex.
Key ESG Issues for FMCGs
We think there are four categories of key ESG developments for FMCGs to watch: (I) corporate reporting and disclosure regimes; (II) green/sustainability claims and labelling; (III) supply chain obligations; and (IV) product packaging and presentation.
Many emerging ESG frameworks cut across sectors. This may be efficient for regulators, but can make identifying sector-specific risks and opportunities more challenging. We have sought to do that below.Continue Reading Green Groceries: Key ESG Issues for the FMCG Industry (including FBOs)
In this episode of Covington’s Life Sciences Audiocast, Sarah Cowlishaw and Ellie Handy discuss the recent changes to the MDR and IVDR. Our speakers discuss the European Commission’s recently adopted Regulation (EU) 2023/607, which extends the transitional periods in the EU Medical Devices Regulation (EU) 2017/745 (the “MDR”) for
Continue Reading Talking Life Sciences Audiocast: Medical Devices – Key Recent DevelopmentsComplex international pharmaceutical supply chains often separate the physical flow of product from financial flows or flows of legal title. Tune in to this episode of Covington’s Life Sciences Audiocast, where Grant Castle, Robin Blaney and Marie Doyle-Rossi, discuss how the EU and UK pharmaceutical rules seek
Continue Reading EU Talking Life Sciences Audiocast: Episode 4 – EU and UK Pharmaceutical Regulation of Tax Structures and Financial Flows – Implications for Global Supply ChainsOn 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
Tune into the third episode of Covington’s Life Sciences Audiocast, where Grant Castle, Stefanie Doebler, and Raj Gathani discuss social media challenges for pharma companies in Europe and the U.S.
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
Tune into the second episode of Covington’s Life Sciences Audiocast, where Sarah Cowlishaw, Ellie Handy, and Léna Beley discuss key developments in the medical device sector in the EU and the UK. Our speakers review the major legal developments for medical devices in the last few years
Continue Reading EU Talking Life Sciences Audiocast: Episode 2 – Key Developments in the Medical Device Sector – State of Play in the EU and UK