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Grant Castle is a partner in the London office practicing in the areas of life sciences regulatory law, with an emphasis on pharmaceutical and medical device regulation.

His advice on general regulatory matters includes: adverse event and other reporting obligations, manufacturing controls, labeling and promotion, and product life cycle management.  He has also advised extensively on EC and national laws governing clinical research, data protection, and the regulatory status of borderline products.

He has developed considerable expertise in coordinating regulatory projects covering jurisdictions outside of Europe, including Canada, South America, Eastern Europe, Russia, Africa, the Middle East, Japan, and Australia.  His transactional work includes advice on regulatory aspects of mergers and acquisitions, licensing, and collaborative arrangements.

Grant is a visiting lecturer at the University of Surrey, on a course leading to a Master of Science in Pharmaceutical Medicine/Clinical Pharmacology; Cardiff University, on a course leading to a Master of Science/Diploma in Clinical Research and on the Postgraduate Course in Pharmaceutical Medicine; and, Cranfield University, on a course leading to Master of Science, Postgraduate Diploma, and Postgraduate Certificate in Medical Technology Regulatory Affairs.  Grant is recognized by Chambers UK, Life Sciences as "excellent," "a knowledgeable lawyer with a strong presence in the industry," who provides "absolutely first-rate regulatory advice," according to sources, who also describe him as "one of the key players" in that area," whilst Chambers Global sources report that "he worked in the sector for many years, and has a thorough understanding of how the industry ticks."  He is praised by clients for his "absolutely first-rate" European regulatory practice.  Legal 500 UK notes that he is “‘highly competent in understanding legal and technical biological issues.”

On 26 January 2023, the UK’s Prescription Medicines Code of Practice Authority (“PMCPA”) published its “Social Media Guidance 2023” (the “Guidance”).

The Guidance is the first of its kind in the UK and is long-awaited. 

The PMCPA is the self-regulatory body that administers and enforces the ABPI Code (the voluntary advertising code that many pharmaceutical companies adhere to in the UK).  The ABPI Code sets out a number of overarching principles but does not address social media in detail.  The PMCPA had some years ago published “digital guidelines” but these were archived for updating.

The first – and probably most important – thing to say about the Guidance is that it (finally) exists.  Social media has become a major compliance headache for UK pharmaceutical companies.  These days a significant number of PMCPA complaints, investigations and adjudications concern corporate or employee social media activity, particularly on LinkedIn.  The absence of clear and codified guidance until now led to a lack of clarity.  Key regulatory principles had evolved through a series of case rulings, which were often highly fact-dependent.  While dissecting cases into the early hours may be interesting for us pharmaceutical advertising lawyers, compliance teams will likely appreciate having codified guidelines to refer to.

Secondly, the Guidance is likely to disappoint anyone hoping for seismic shifts in the PMCPA’s regulatory approach.  Much of the Guidance aligns closely to rules and principles that had developed in the Authority’s case history.  It also broadly aligns with EFPIA’s and IFPMA’s recently published “Guidelines Concerning the Use of Social Media and Digital Media Channels” (see our blog post).

Continue Reading UK PMCPA Publishes First Ever Guidance to Pharmaceutical Companies about Social Media

On 28 September 2022, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and European Federation of Pharmaceutical Industries and Associations (EFPIA) published joint guidelines concerning the use of social media and digital media channels by pharmaceutical companies (Joint Digital Guidelines).  IFPMA  and EFPIA are umbrella trade bodies for the innovative pharmaceutical industry on the global and European stages, respectively.

The Joint Digital Guidelines are timely.  Digital communications and the use of social media have become hot compliance topics for the pharmaceutical industry, both in Europe and globally.  Actors in the healthcare world increasingly use digital communication channels; many clinicians, patients and patient organizations actually prefer to receive content digitally.  With more content comes higher compliance risk.  Digital communications, particularly over social media, can spread fast across borders and are often publicly accessible. 

It is no surprise that a very significant number of pharmaceutical advertising cases in European markets now concern digital channels or social media.  This certainly reflects our experience; and this is an area where our pharmaceutical advertising experts are continually advising clients.

Continue Reading IFPMA and EFPIA Publish New Joint Guidance Note on Social Media and Digital Channels

In three days’ time (on May 26, 2022), the EU Regulation on In-vitro-Diagnostic Medical Devices (the “IVDR”) becomes applicable in Europe.  But what will this mean for companies who sell in-vitro-diagnostic medical devices (“IVDs”) in the UK?

Following the UK’s exit from the EU, the IVDR will not become effective within Great Britain (i.e., England, Scotland and Wales), but it will apply to Northern Ireland.  Companies operating in both the EU/Northern Ireland and Great Britain will therefore need to be aware of the different obligations applicable to IVDs between these jurisdictions.

IVDR Background

The IVDR will replace the existing EU IVD Directive (the “IVDD”), but will not change the fundamental principles of how IVDs are regulated.  IVDs will be still be subject to a system of self-certification, notified body assessment (in certain instances) and CE marking.  Most notably, under the current system, ~90% of IVDs are self-assessed for conformity and self-certified by the IVD’s manufacturer.  By contrast under the IVDR, the new classification rules mean that this will be flipped to require ~90% of IVDs to be subject to notified body assessment.  This creates practical issues for manufacturers, since there are currently only seven notified bodies who are authorized to conduct conformity assessments under the IVDR.

Continue Reading What do companies supplying IVDs to the UK market need to know about the IVDR?

On 20 January 2022, the National Institute for Health and Care Excellence (NICE) announced major changes to the processes and methods by which it assesses the cost-effectiveness of medicines and other health technologies.

NICE is an independent expert body tasked with appraising the cost-effectiveness of medicines and recommending whether a product should be funded by the National Health Service (NHS).  NICE is therefore considered the gatekeeper for medicines reimbursement; a positive recommendation obliges the NHS to fund a product.

NICE has announced a suite of detailed changes, which mark the culmination of a two-year-plus long “methods review”.  NICE will implement the changes in new guidelines.  They are due to take effect from February 2022.

Continue Reading UK Aims for Faster and Fairer Access to Innovative Treatments as NICE Announces Major Changes to its Health Technology Appraisals Process

On 20 March 2020, the European Medicines Agency (EMA) published Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic (the Guidance).  The EMA jointly developed the Guidance with working groups from the European Commission and the national Heads of Medicines Agency (HMA).

The Guidance provides information on changes and protocol deviations that

NHS England has recently published draft proposals on how it plans to approach doing commercial deals with pharmaceutical companies for branded medicines. This draft “Commercial Framework” is now open for comment and consultation (stakeholders can submit their views here). The consultation period ends on 10 January 2020, with Commercial Framework expected to be finalized

French “anti-gift” rules strictly regulate the relationship between the life sciences industry and healthcare professionals (“HCP”) and the possibility for companies active in the health sector to offer benefits, in cash or in kind to healthcare professionals, medical students or associations representing them.  This includes a general prohibition against offering such benefits.

To strengthen the

On 21 February 2019, the European Commission wrote to the European Medicines Agency (“EMA”) and the Heads of Medicines Agencies of the EU-27 Member States concerning the acceptability of UK batch testing after Brexit (see the letter here).  The letter seeks to address concerns that a number of pharmaceutical companies will not have been

Raj Gathani, a Trainee Solicitor in Covington’s London office, contributed to this post.

On 1 September 2015 the General Court issued an interim order in favour of Pari Pharma GmbH (“Pari”) to suspend the European Medicines Agency’s (“EMA”) decision to grant a third-party, Novartis Europharm Ltd (“Novartis”), access to certain documents prepared during the Marketing Authorisation (“MA”) application process (the “MA Documents”).  The MA Documents at issue included EMA Assessment Reports on similarity and superiority between Pari’s product (Vantobra) and Novartis’ product (TOBI Podhaler), which has an EU MA as an orphan medicine.  Novartis made the request to the EMA for access to the MA Documents under the Transparency Regulation 1049/2001.  The main case is currently pending before the General Court (Case T-235/15).

The thrust of Pari’s argument before the General Court was that the MA Documents contain Pari’s regulatory strategy for obtaining MA approval, disclosure of which might cause Pari serious and irreparable financial damage.  The President of the General Court acknowledged that the case raised complex issues in the area of confidentiality and stated that the main proceedings (rather than an interim hearing) is the appropriate forum to address such issues..  As such the President considered that the MA Documents fell under a presumption of confidentiality  and ordered the EMA not to disclose the MA Documents.
Continue Reading General Court Makes Interim Order to Protect Confidentiality in Pari Pharma Transparency Case

By Colin Warriner

Since 1 July 2015, anyone in the UK selling medicines online to the general public must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA), and be on the MHRA’s list of UK registered online retail sellers.  In addition, those retailers now need to display, on every relevant page of their websites, the new EU common logo, which will hyperlink directly to the MHRA’s list of registered online sellers.  The MHRA has issued guidance on registration and the use of the logo.

Continue Reading Mandatory registration and logo for UK online sales of medicines