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
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
The UK Government has confirmed that it is committed to implementing the new EU Clinical Trials Regulation (EU) 534/2014 (“EU CTR”) into UK law post-Brexit. The EU CTR entered into force in 2014 but will not apply until 6 months after the European Commission issues a notice confirming that the new EU clinical trials portal
The Food and Drink Federation (“FDF“) has published a report on the potential impact of rules of origin on UK food and drink exporters in the likely event that the UK ceases to be part of the EU customs union after Brexit. Rules of origin are the detailed content requirements that determine whether goods are
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
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
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
The European Medicines Agency has published a Practical Guidance concerning the steps that centralised Market Authorisation Holders will be required to take before Brexit.
Agnès Saint-Raymond, MD, Head of International Affairs at the European Medicines Agency (“EMA”), recently urged pharmaceutical companies to be “proactive” in preparing for Brexit, as there is still uncertainty around a potential Brexit transition period.
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
European Medicines Agency (EMA) has released a business continuity plan dealing with the potential implications of Brexit. EMA, which is currently established in London, will be required to transfer the Agency’s headquarters to another EU Member State. With the aim to conserve Agency’s capacities to protect public and animal health, EMA has issued a press
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
Leaving the EU will require the most comprehensive re-writing of the UK’s statute book ever undertaken. Parliament must unpick over 40 years of integration between the UK and the EU legal systems and ensure no gaps are left in the process. The Government’s solution, the highly anticipated, formerly ‘Great’, Repeal Bill, is due to be published
With the negotiations for the UK’s withdrawal from the EU formally under way, the UK healthcare sector is calling on the UK Government to make patient safety and access to medicines a priority in negotiations – and it appears from a recent letter to the Financial Times (FT) that Government ministers are listening. On 3
The UK Government has made clear that it intends to end the jurisdiction of the Court of Justice of the EU (“CJEU“) in the UK post-Brexit. This will, unless agreed otherwise in the negotiations, result in litigants losing the ability to make references to the CJEU on questions of EU law. In the meantime, the
The 2017 General Election campaign is up and running. There are strict rules on campaign spending by non-political parties during the 365 days leading up to a General Election, which apply retrospectively back to 9 June 2016 until 8 June 2017. With businesses engaging with the British public about important political issues like never before,
UK Prime Minister Theresa May has today announced that she intends to trigger a General Election to take place on 8 June 2017. The announcement is the latest unexpected twist in an unpredictable 12 months in British politics. What does this surprise development mean for the Brexit process? Read the full blog here.
The Brexit process gets officially underway this week when the UK formally notifies the European Council of its intention to withdraw from the EU on 29 March 2017. The road ahead is untested and uncertain, as the UK will be the first EU Member State ever to leave the Union. Hogan Lovells will be hosting
UK Secretary of State for Health, Jeremy Hunt, has stated in a Health Select Committee meeting that he does not expect the UK to remain part of the European Medicines Agency (“EMA”) or the EU medicines regulatory framework post-Brexit, but that the UK should seek a very close working relationship with the EMA and the
The Internet of Things (“IoT”) connects markets and supply chains around the world. Industry, governments and consumers around the world are embracing IoT technologies to improve research and public policy, to accelerate service delivery and to monitor global development programs across healthcare, agriculture, natural resource management, climate, and energy sectors. Industry experts project that between
Many digital platforms attract consumers and businesses on a global basis. It is a challenge for national regulators to enforce competition law and other regulatory provisions against such international players. Germany´s Federal Minister of Justice, Heiko Maas, argued in a similar way in an interview with the German newspaper Handelsblatt on 5 October 2016.
The stage is set for the Euro-drama of our time. We know that giving effect to the UK’s vote for Brexit could require as many as four sets of distinct but closely linked negotiations, or “acts”, dealing with the terms of: the UK’s withdrawal from the EU; the UK’s future relationship with the EU after
The new May Government has now been fully established and has begun getting to work. Judging by last week’s notable developments, foreign affairs is top of the agenda. Brexit diplomacy: Good cop, bad cop? The Prime Minister made her first official visits to Germany and France last week to meet Angela Merkel and François Hollande.
Following on from last week’s comments from Donald Tusk and Jean-Claude Juncker about when the EU expects the UK to trigger Article 50 of the Treaty on the European Union, comments by British officials in the last week have shed further light on the road to Brexit ahead. What are the UK’s “constitutional requirements” for