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Category Archives: UK & EU Public Law & Policy

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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

Data Without Borders: Hogan Lovells Winnik Forum Addresses International Considerations for the Growth and Development of a Connected World

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

Statute of Liberty: LIBERTY to prioritise safeguarding of the HRA

These are interesting, and challenging, times for human rights law in the UK. There has been a remarkable growth in awareness of human rights as offering protections to those throughout society, and on an international scale. It is an issue that is now firmly on the agenda in boardrooms, and in the media. But there

Brexit: a play in four acts?

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

This is the house that Brexit built

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.

Another week of Brexit developments: 5 – 11 July 2016

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

A recap on Brexit: what do we know so far?

Today marks twelve days since the UK voted to leave the European Union.  We examine below what we have learnt about what lies ahead, as the dust is settling in Brussels and in Westminster. ARTICLE 50 A deliberate act Several aspects of Article 50 of the Treaty on the European Union (“Article 50” and “TEU“)

Waste not, want not: The High Court finds that HMRC breached legitimate expectation on landfill tax

The High Court, in the recent case of R (Biffa Waste Management Services Ltd) v the Commissioners for HMRC [2016] EWHC 1444 (Admin), has provided much needed clarification on taxpayers’ entitlement to rely upon rulings by HMRC where the ruling is general in nature but framed to apply only to specific transactions. Facts The claimant,

Adoption of the French Government Order Relating to Study Involving Human Persons Pursuant to the Public Health Law Dated 26 January 2016

Regulation No. 536/2014 repealed Directive 2001/20/EC of 4 April 2001 on the approximation of the laws, regulations, and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. The main purpose of the Regulation is to harmonize and simplify

Mullet over: Court of Appeal reaffirms judicial respect for expert statutory decision-makers but awards compensation for de facto deprivation of rights

The Court of Appeal found in R. (on the application of Mott) v Environment Agency [2016] EWCA Civ 564 that a decision significantly to reduce the number of salmon the Claimant was permitted to catch was not irrational. However, it did breach his property rights under Article 1 of Protocol 1 (“A1P1”) to the European

Closing the stable door after another horse has bolted: The Information Rights Tribunal confirms the persuasiveness of other public authority decisions on disclosure of similar commercially confidential information

The First-tier Tribunal (Information Rights) (“FtT“) has published an interesting decision on the disclosure of commercially confidential information.  In John Eustace v The Information Commissioner, Southampton City Council (the “Council“) was ordered to disclose commercial information relating to the revenue stream it received from bus stop advertising, in part because other local authorities had been

Open Government National Action Plan aims to increase transparency in government over the course of 2016-2018

Following a Conservative manifesto commitment in 2015 to increase transparency in government, the Cabinet Office has published the UK Open Government National Action Plan 2016-2018. This is the third National Action Plan (“NAP“) since the United Kingdom co-founded the Open Government Partnership in 2011, which now includes 69 countries. The new NAP makes 13 commitments