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
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
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
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
A “Brexit Health Alliance” (BHA) has been formed to bring together a diverse range of UK stakeholders in the healthcare industry and provide a single voice for the sector on Brexit-related issues. Members of the BHA include NHS organisations, industry associations, universities, research organisations and charities, the Royal Colleges, such as NHS Confederation, NHS Providers,
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 French sunshine regulations require industry to report certain agreements along with the fees and other benefits provided to various stakeholders in the healthcare sector. Sunshine regulations were amended in January 2016 to increase transparency. Some specifics of these changes were partly established by an implementing decree dated 28 December 2016. Through the publication of
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
CPR 54.5(2) is clear: the time limit for filing the claim form for judicial review may not be extended by agreement of the parties. The justification for the rule is well-known. Undue delay sits uncomfortably with good administration since public bodies need certainty as to the validity of their decisions – and third parties need
What good is a cricket game without an umpire? We explore potential options for dispute resolution in the future UK-EU trading relationship. Read the full blog here.
The UK Government’s Brexit white paper asserted that Brexit will end the jurisdiction of the CJEU (Court of Justice of the European Union) in the UK. However, the reality is more complex. We explain why the CJEU’s significance cannot be ignored. Read the full blog here.
Starting in April 2017, the European Medicines Agency (“EMA”) will expand the Multinational Assessment Team (“MNAT”) Initiative to post-authorisation assessments. From this date, the MNAT Initiative will allow national competent authorities not only to participate actively in the development of new medicinal products, but also to be involved in the extensions of marketing authorisations for
A change in government policy can sometimes have a profoundly adverse effect on businesses, particularly if that change is unexpected or sudden. Businesses, particularly those in highly regulated sectors, often rely on “clear assurances” from Government in relation to its policy objectives and areas of focus (and funding) as a basis for operating or investing
On 27 December 2016, the Belgian Law of 18 December 2016 concerning various health-related matters (“the Sunshine Act “) was adopted by the Belgian Ministry for Public Health. The Sunshine Act introduces several substantial changes to the current Belgian legal and regulatory framework for medicinal products and medical devices. Background The Sunshine Act imposes a
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
On 19 January 2017, major modifications were adopted in France to the regulations on interactions between the industry and healthcare professionals (and other stakeholders). These new regulations, a.k.a. “anti-benefits regulations”, will entail major changes in the industry’s compliance procedures relating to payments and other transfers of value to those stakeholders. The new rules are
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was adopted and entered into force in 2014. The European Medicines Agency (“EMA”) has recently confirmed that the Agency is currently on schedule to introduce the new related EU portal
The French sunshine regulations require industry to report certain agreements along with the fees and other benefits provided to various stakeholders in the healthcare sector. These regulations also govern the declarations of interests that experts must file in relation with their interactions with the industry. Sunshine regulations were amended in January 2016 to increase transparency.
On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory conference concerning the optimisation of the development of advanced therapy medicinal products (“ATMPs”) to meet patient needs (“the ATMP conference”). Background The aim of the ATMP conference was to discuss initiatives to improve advanced
On 8 December 2016, the European Medicines Agency (“EMA”) organised a workshop in collaboration with the European Commission to gather the views and proposals from stakeholders on the adaptive pathways approach. The aim of the workshop was to gather stakeholder feedback in light of the practical experience gained during the adaptive pathways pilot project EMA