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Focus on Regulation

Category Archives: UK & EU Public Law & Policy

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Why the Repeal Bill is central to making Brexit a success

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

New UK Brexit Health Alliance Formed

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,

General Election 2017: Comply with the Campaigning Rules

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,

Finger on the polls – May calls for snap General Election

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.

French Sunshine Regulations: The Puzzle Now Completed and in Force

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

What you need to know before Brexit gets underway this week

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

Calling time on time limits?

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

Brexit: the ball is in which court?

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.

Extension to the EMA’s Multinational Assessment Team Initiative as of April 2017

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

Predicting the winds of change: business investment decisions and unexpected shifts in government policy

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

New Belgian Sunshine Requirements applicable to all pharmaceutical and medical devices from 1 January 2017

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[1].  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 to Seek Close Relationship with EMA Post-Brexit

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

France Tightens Grip on Industry Payments to HCPs (again)

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

EMA Update concerning EU Clinical Trials portal and database

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

New French Sunshine Regulations About To Kick In

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.

EMA on optimising the development of advanced therapies

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

EMA hosts workshop on adaptive pathways

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

Revisions to Clinical Data Publication Guidance extends scope of EMA disclosure power to clinical data submitted before 1 January 2015

On 9 December 2016, the European Medicines Agency (“EMA”) organised a webinar for industry associations. At the webinar, the EMA presented an update concerning the implementation of the EMA policy on publication of clinical data for medicinal products for human use (“Policy 0070”) and revisions to the guidance to industry. Among the new elements introduced

Statutory Instruments: The House of Commons holds all the cards

On 1 December 2016, the Government published its response to the Strathclyde Review, the inquiry ordered by the then Prime Minister, David Cameron, following the Government’s tax credits defeat in the House of Lords last year. That defeat brought into question the relationship between the House of Commons and the House of Lords, and the

New Belgian Innovation Office to Accelerate Availability of Novel Medicines

In July 2016, the Belgian Agency for Medicines and Healthcare Products (“FAMHP”) took steps to establish a National Innovation Office as part of the European Union (“EU”) Innovation Network. The National Innovation Office is currently being established by the FAMHP. It is expected to become functional in the first quarter of 2017. The National Innovation