The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related clinical trials that would need to be amended in the event of a “no deal” scenario, i.e. if the UK leaves the EU on 29 March 2019 without the framework
Category Archives: UK & EU Public Law & Policy
Subscribe to UK & EU Public Law & Policy RSS FeedNo-deal Brexit: New guidance on producing and labelling food products
In the final batch of technical notices, the UK Government has provided guidance on what impact traders can expect on food labelling and packaging in the event that the UK exits the EU without a Withdrawal Agreement on 29 March 2019. Producing and labelling food Currently, EU rules, such as EU Regulation 1169/2011 or “FIC”,
No-deal Brexit: Technical notices on trading goods published
The UK Government has released a further batch of technical notices, providing guidance to businesses on the implications of an exit from the EU without a Withdrawal Agreement on 29 Mach 2019. Three of these notices will be of particular interest to businesses trading goods in other EU Member States: 1. Trading under the mutual
HMA-EMA’s work programme on availability of authorised medicines for human and veterinary use includes measures for Brexit
On 23 August 2018, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the network of the National Competent Authorities in the European Economic Area (EEA), published the work programme of their joint task force regarding the availability of authorised medicines for human and veterinary use. The HMA-EMA task force was created
UK Government publishes first no-deal Brexit notices for food
The Government has released its first batch of technical notices which aim to prepare UK citizens and businesses for an exit from the EU without a Withdrawal Agreement on 29 March 2019. Of most relevance to food businesses are the notices on developing genetically modified organisms (“GMOs“) and producing and processing organic foods. Under the
UK Government Publishes Guidance for Life Sciences Companies on Brexit Transition
The UK Government has published guidance for life sciences companies on the Brexit implementation period, which is intended to take effect from 30 March 2019 to the end of 2020. If the draft Withdrawal Agreement is finalised by the UK and EU, during the implementation period the UK will no longer be an EU Member
Updated EMA guidance on centrally authorised medicines raises new considerations for Brexit preparations
On 19 June 2018, the European Medicines Agency (EMA) published updates to its Brexit Q&A document for human and veterinary medicines authorised via the centralised procedure and to its practical procedural guidance on making Brexit related changes to the authorisations for those products. The updated version (“Rev 03”) of the EMA Q&A document includes new
Implications of European Commission’s proposal for a Regulation to modify existing EU rules to allow manufacturers to apply for new approvals in 27 EU Member States to replace their UK type-approvals following Brexit
On 4 June 2018, the European Commission adopted a proposal for a Regulation to modify existing EU rules to allow manufacturers of vehicles to obtain new approvals from the 27 EU Member States who will remain post-Brexit to replace their existing UK-type approvals. Although the proposed Regulation focuses specifically on vehicles it could be interpreted
UK Government Responds to Brexit Life Sciences Regulatory Recommendations
The UK Government has published a response to the recommendations set out in the Health and Social Care Committee’s Report dated 21 March 2018 on “Brexit: medicines, medical devices and substance of human origin”, which considered the regulatory arrangements needed for the safe and effective supply of medicines and medical devices post-Brexit (see our blog
UK Parliamentary Report Published on the Impact of Brexit on the Pharmaceutical Sector
The Business, Energy and Industrial Strategy Committee, a parliamentary select committee, has published a report on the consequences of Brexit on the UK pharmaceutical industry. The report examines the impact of different outcomes of the UK/EU negotiations, including a “no deal” scenario, on tariff barriers, non-tariff barriers (e.g. border delays), regulatory alignment, trade opportunities, skilled
Fair’s fair: Supreme Court clarifies law on unfairness and equal treatment in judicial review
In R (oao Gallaher and others) v CMA [2018] UKSC 25, handed down last week, the Supreme Court has clarified that substantive unfairness is not an established ground of judicial review and that likewise there is no “distinct principle” of equal treatment. Case background In March 2003, the Office of Fair Trading (“OFT“) (a predecessor
UK Parliamentary Committee Publishes Life Sciences Brexit Negotiation Recommendations
The UK House of Commons Health and Social Care Committee has published the findings of its six-month long investigation into the impact of Brexit on medicines, medical devices and substances of human origin. The Committee’s report sets out recommendations for the UK Government in its negotiations with the EU on the terms of the UK’s
Unfit to remit: First-Tier Tribunal must make its own decision on whether information relating to Blairs’ post-office appointments must be disclosed
In relation to a Freedom of Information Act 2000 (FOIA) request for details of Tony Blair’s private appointments after his tenure as Prime Minister, the Upper Tribunal (“UT”) has confirmed that the First-Tier Tribunal (“FTT”) cannot remit a decision to the Information Commissioner for fresh consideration. The UT was also critical of the FTT’s approach
Brexit – what’s next for medical devices?
On 22 January 2018, the European Commission released a notice to stakeholders concerning the United Kingdom’s (“UK”) possible withdrawal from the European Union (“EU”) and the EU rules in the field of industrial products, including medical devices and in vitro medical diagnostic medical devices. The notice presents the steps that manufacturers of medical devices and
European Commission Publishes Guidance on Brexit and UK Food Exports
On 1 February 2018, the European Commission issued a notice on the impact of Brexit for food products originating from the UK. The Commission confirmed that, in the absence of a transitional agreement, the UK will become a ‘third country’ from the date of its withdrawal from the EU. This will impact a number of
Freedom of Information Code of Practice Consultation
The Government is consulting (link below) on various revisions to the Code of Practice for public authorities on their obligations under the Freedom of Information Act 2000 (the “Act“). The revisions, which are intended to reflect developments in good practice, include the following: additional guidance on fundamental principles, such as how to define “information” and
UK Modern Slavery Act – are tougher disclosure requirements on their way?
Disclosure requirements under the UK Modern Slavery Act 2015 (‘MSA’) have pushed many businesses operating in the UK to gather and interrogate information about human rights risks across their operations and supply chains – but for some advocates of the MSA and campaigners, the new disclosure regime has fallen short. The shortcomings are addressed to
UK Government Announces Life Sciences Sector Deal
The UK government has published a White Paper setting out its new Industrial Strategy and, as part of that strategy, has agreed a Sector Deal with the UK life sciences sector. The White Paper covers all industries and identifies the life sciences sector as having particular strategic value in the UK, generating £64 billion of
The French Competition Authority Wants to Lower Prices of Pharmaceuticals
On November 21, 2017, the French Competition Authority (“FCA”) announced the launch of a new sector inquiry relating to the functioning of competition in the pharmaceutical sector. This inquiry will lead the FCA to make recommendations to the French President Macron and the government on how to increase competition and lower prices of pharmaceuticals. The
House of Lords Committee critical of “unacceptably wide” powers in the Withdrawal Bill
The House of Lords Delegated Powers and Regulatory Reform Committee has published a report on the European Union (Withdrawal) Bill which sets out its concerns on the “unfettered discretion” and “excessively wide legislative powers” given to Ministers by the Bill. The report is particularly critical of the so-called Henry VIII powers granted to Government by
UK MHRA Publishes Guide to the New EU Medical Device and IVD Regulations
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published an interactive guide to assist companies with understanding the requirements of the new EU Medical Device Regulation (“MDR”) and In Vitro Diagnostic Medical Device Regulation (“IVDR”). The MDR and IVDR entered into force on 25 May 2017. Most of the requirements under the MDR
FDA, EU Regulators Agree to Share Unredacted Inspection Reports and Other Confidential Information
The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which expands the scope of the current confidentiality arrangements that apply to the cooperative law enforcement activities conducted by the regulators. The new confidentiality commitment allows the regulators to share
Lord Justice Jackson suggests extending Aarhus Rules to all JR claims… again
On 31 July, Lord Justice Jackson published a report containing a series of proposals on civil litigation costs. While mainly focused on fixed recoverable costs, the report also contained a radical suggestion: to extend the claimant-friendly rules applying to environmental claims (which derive from the Aarhus Convention) to all judicial review claims. However, this is
HRLA panel discusses growing significance of commercial human rights post-Brexit
Before a central London audience earlier this month, Charles Brasted, partner and head of public law and policy at Hogan Lovells, and leading QCs Tim Ward, Jessica Simor and Gerry Facenna reflected on the likely impact of the UK’s withdrawal on commercial human rights law and the constitutional settlement in England and Wales. There was