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Grant H. Castle
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.
Mr. Castle 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. Mr. Castle 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.”
- Regulatory advice to many of the major national and multinational pharmaceutical companies and a wide array of biotechnology, diagnostic, medical device, and consumer product manufacturers in the United States, United Kingdom, mainland Europe, and elsewhere.
- Assistance to clients with applications for the centralized approval of medicinal products and for EC orphan drug designation, and with regulatory issues in the national approval process for medicines, including the EC decentralized and mutual recognition procedures.
- Regulatory advice to the Pharmaceutical Research and Manufacturers of America (PhRMA), the primary US industry trade association, and participation in PhRMA European Regulatory Team and the PhRMA Pharmacovigilance Working Group.
- Participation in formal and informal good manufacturing practices (GMP), good clinical practices (GCP), clinical trials, advertising, borderline, drug safety, and pharmacovigilance regulatory and enforcement proceedings before the European Medicines Agency (EMEA), national authorities, courts, and self-regulatory bodies.
- Participation in pharmaceutical and medical device reimbursement proceedings before the UK’s National Institute
- Judicial review proceedings in the UK and EC courts, including the first challenge to a Community marketing authorization for a medicinal product in the European Court of First Instance.
- Participation in compliance-related investigations and initiatives in respect of alleged breaches of medicines advertising, anti-bribery, clinical trials, and pharmacovigilance rules.
- Product defense resulting from regulatory challenges to product claims and borderline product classifications.
Previous Experience
- Glaxo Group Research, Medicinal Chemist (1991)
January 16, 2020
London—Covington represented Illumina on its partnership with Genomics England, to sequence up to 500,000 whole genomes for the NHS Genomic Medicine Service. This partnership is part of the wider ambition to analyse up to 5 million genomes by 2024, to enable the UK to maintain its position as a global leader in genomics. Under this partnership and guided by ...
November 14, 2019, Inside EU Life Sciences
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 ...
August 22, 2019, Inside EU Life Sciences
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 ...
July 30, 2019, Covington Alert
On July 29, 2019, the Court of Justice of the European Union (“CJEU”) issued its judgment in Case C-359/18 P, Shire Pharmaceuticals Ireland v. EMA, dismissing the European Medicines Agency’s (“EMA”) appeal and reconfirming the position set by the General Court. Covington represented Shire Pharmaceuticals Ireland (“Shire”), which was recently acquired by Takeda.
February 26, 2019, Inside EU Life Sciences
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 able...… Continue Reading
January 10, 2019, Covington Alert
On January 7, 2019, EU Regulation 2019/5 was published in the Official Journal of the European Union. The Regulation is part of a package that makes numerous significant amendments to the EU’s regime for veterinary medicines and medicated feed, and it also made some key changes to the EU financial penalties regime.
December 12, 2018, Covington Digital Health
The UK’s National Institute for Health and Care Excellence (NICE) has recently published an evidence standards framework for DHTs (the Standards), available here. It did so through a working group led by NHS England, but supported by representatives from Public Health England, MedCity and DigitalHealth.London. The Standards cover DHTs, such as apps, programs ...
October 15, 2018, Covington Alert
On August 23, 2018, the UK Government published several technical guidance notices relating to the regulation of medicines and medical devices in the event of a “no deal” or “hard” Brexit, i.e., a scenario where the EU and UK fail to conclude a withdrawal agreement and an associated transitional period and where the UK becomes a “third country” from midnight CET ...
United Kingdom
2018, Global Legal Insights to: Global Legal Insights - Pricing & Reimbursement 2018, 1st Ed.
August 17, 2018
LONDON—Covington has advised Sensyne Health on medical device regulatory and data protection matters in connection with its £60 million IPO on London’s AIM market. The firm also represented Sensyne Health in negotiating strategic research and data processing agreements with the Chelsea and Westminster Hospital NHS Foundation Trust, the Oxford University ...
July 30, 2018
SILICON VALLEY—Covington advised GlaxoSmithKline on its multi-year collaboration with and $300 million equity investment in 23andMe. GSK will become 23andMe’s exclusive collaborator for drug target discovery programs. The collaboration will focus on research and development of innovative new medicines and potential cures using human genetics as the basis for ...
BIA Head Attacks Rapporteur Reallocation, But Welcomes Further Clarity On Transition Period
April 23, 2018, The Pink Sheet
Grant Castle is quoted by The Pink Sheet in an article regarding comments from head of the UK BioIndustry Association stating that authorities are jumping the gun by reallocating all UK centralized rapporteurships to other EU member states before it is clear whether there will be some form of continued regulatory relationship between the UK agency, the MHRA, and ...
March 22, 2018, Covington Alert
European General Court confirms that a new medicinal product containing the same active substance as a company’s existing medicinal product may be entitled to its own period of orphan exclusivity.
February 13, 2018, Covington Digital Health
On February 1, 2018, Covington’s Digital Health team hosted a webinar examining U.S. and EU regulatory issues for digital health associated with pharmaceuticals. Here are some key takeaways from that webinar: Neela Paykel from Proteus Digital Health, noted that “you need to think outside the box for how to engage, whether you’re a pharma company...… Continue ...
December 19, 2017, Covington Digital Health
On November 14, lawyers from Teva Pharmaceuticals and Covington & Burling discussed digital health innovation from a medical device regulation perspective in the U.S. and the EU. The presentation by Rachel Turow, Executive Counsel – Regulatory Law, Teva Pharmaceuticals, and Grant Castle, Scott Danzis, Sarah Cowlishaw, and Christina Kuhn of Covington, covered ...
European approvals face delay from agency move
October 25, 2017, EP Vantage
Grant Castle is quoted in an EP Vantage article examining how the move of the European Medicines Agency from London will impact European drug approvals. According to Castle, the main consequence of lower staff numbers could be longer waiting times to file drugs. “Because of the regulatory timetable there isn’t a huge amount of scope for delaying reviews, but ...
What Brexit means for drug regulation
July 14, 2017, Pharmafile
Grant Castle is quoted in a Pharmafile article regarding how Brexit may affect drug regulation. “Even if we enter into a close free-trade agreement, the UK will lose influence in the development of pharmaceutical legislation and policy, and will also lose influence in the pharmaceutical regulatory procedures,” says Castle. “And that must inevitably mean that ...
2005-present
Mr. Castle has written numerous publications in legal and regulatory literature and contributed to technical literature in chemistry.
Pharmaceutical, medical device, data privacy, and borderline products regulatory issues
2005-present
Mr. Castle frequently lectures on these issues.
2005-present
Mr. Castle has written numerous publications in legal and regulatory literature and contributed to technical literature in chemistry.
POLITICO Pro Morning Health Care, presented by Lilly: Brexit wobble — WHO DG candidates compete
November 4, 2016, Politico Pro
Brian Kelly and Grant Castle are quoted in a Politico Pro “Morning Health Care” article regarding the High Court ruling that the UK government does not have the legal power to invoke Article 50 without Parliamentary approval. According to Kelly, “This presents an opportunity for individual companies and the industry to engage with members of Parliament to ensure ...
October 6, 2016, EP Vantage
Grant Castle is quoted in an EP Vantage article regarding the effect of Brexit on life science funding and strategy. According to Castle, “Particularly if the UK heads for a ‘hard Brexit,’ the UK will be a less attractive venue for investment by pharma. It’s one of the sad side effects of all this.”
The implications of Brexit for the UK’s pharma regulations, companies and infrastructures
October 4, 2016, ABPI Legal Day 2016
August 5, 2016, FDA Week
Grant Castle is quoted in an FDA Week article regarding the likelihood that the UK will remain part of the Mutual Reliance Initiative between the U.S. and EU. "If the UK does Brexit, but executes the European Economic Area (EEA) Agreement, as Norway, Iceland and Liechtenstein have done, it would continue to implement all new EU pharmaceutical rules and ...
July 11, 2016, Covington Alert
The UK recently voted to leave the European Union in an advisory referendum. The impact of Brexit on medical devices regulation in the medium-to-long term will very much depend on the form a post-Brexit UK will take, the relationship that the UK chooses to have with the EU, and indeed the relationship that the EU is willing to accept. That will not become clear ...
2019
Our Brexit Task Force is staffed by senior lawyers and advisors across London, Brussels, and Washington to monitor events and to keep clients apprised of legal, regulatory, and policy developments. We are advising clients across a wide range of businesses and industries on the impact and implications of Brexit, including on strategic policy and regulatory ...
UK science brains seek truce after Brexit
June 30, 2016, Politico
Grant Castle is quoted in a Politico article regarding Britain’s desire to continue its dominance in health research. Commenting on the possibility of having Britain stay in the single market, Castle says, “I don’t think that’s a practicality now.” He continues, “I would think that access to the country would be tightened…given the strength of feeling on ...
June 28, 2016, Bloomberg
Grant Castle is quoted in a Bloomberg article regarding the implications of Brexit on the future of the pharmaceutical industry and the drug approval process. According to Castle, the best that the UK regulator could hope for would be an observer status on European Medicines Agency committees. That loss of influence could make the UK less appealing, because it ...
June 27, 2016, The Legal Intelligencer
Grant Castle is quoted in a Legal Intelligencer article regarding the regulatory impact of Brexit. Commenting on the Food and Drug sector, Castle says, “The UK will inevitably diminish in significance when it comes to the regulation of pharmaceuticals and a venue where drug companies are going to want to be based. Historically, U.S. companies wanted to operate ...
June 27, 2016, Covington Alert
Last week, the UK voted in an advisory referendum to leave the European Union. The next steps are not yet clear, but the referendum may have significant implications for the pharmaceutical industry in the UK and for international companies operating in the UK. Its impact will very much depend on the form a post-Brexit UK will take, the relationship that the UK ...
June 24, 2016, Politico
Grant Castle is quoted in a Politico article regarding the effect of Brexit on the future location of the European Medicines Agency. Castle predicts that the EMA is inevitably going to leave the UK. “Given the strength of feeling on immigration,” it looked unlikely the country would opt for a European Economic Area relationship, since that would mean continuing ...
UK Votes to Leave the EU
June 24, 2016, Covington Alert
The UK has voted to leave the European Union in an advisory referendum. 52% leave - 48% remain. Were the UK to leave the EU, this would have significant implications for the UK and for international businesses operating in the UK. The longer term impact of the decision on the regulatory framework for the UK will depend, in part, on the relationship that the UK ...
May 8, 2016, Financial Times
Peter Bogaert and Grant Castle are quoted in a Financial Times article regarding the effect Brexit would have on the UK pharma industry. According to Bogaert, commenting on the important relationship between the European Medicines Agency and the UK’s Medicines and Healthcare Products Regulatory Agency, “Brexit would be a loss for both sides.” Castle adds that ...
Covington Represents Underwriters in Senseonics' IPO
March 24, 2016
NEW YORK - Covington advised the underwriters in the $45 million initial public offering of common stock of Senseonics Holdings, Inc. The offering closed on March 23, 2016. Shares of Senseonics trade on the NYSE MKT under the ticker “SENS.” Senseonics develops continuous glucose monitoring systems for patients with diabetes. Its Eversense product consists of ...
Fate of EU drugs agency hangs in Brexit balance
February 17, 2016, Politico
Grant Castle and Robin Blaney are quoted in this Politico article discussing the potential impact of “Brexit” on the pharmaceutical sector in the UK and Europe. According to Castle, the “only rational alternative” to EU membership is for the U.K. to become a member of the European Economic Area, as this arrangement would make it so the practical and operational ...
Legal Aspects of Manufacturers Reporting Obligations" and "Legal Aspects of FSCA
January 26, 2016, EC Med Devices Vigilance System and Post Marketing Surveillance
September 14, 2015, Inside EU Life Sciences
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 ...
July 23, 2015, Inside EU Life Sciences
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...… Continue Reading
June 2015, Intellectual Property & Technology Journal
Examining Unlicensed Use and Off-label Use
May 19, 2015, Informa Life Sciences’ 24th Annual EU Pharmaceutical Law Forum
Update on Medical Devices and In-vitro Diagnostics
February 27, 2015, Annual Conference on EU Law in the Pharmaceutical Sector 2015
Legal Aspects of Manufacturers Reporting Obligations" and "Legal Aspects of FSCA
January 27, 2015, EC Medical Devices Vigilance System and Post Marketing Surveillance Conference
Regulatory enforcement trends in Europe and the Financial Penalties Regulation
November 6, 2014, Health Authority (FDA, MHRA, EMA, CFDA) and Related Enforcement Issues Webinar
October 27, 2014, Covington E-Alert
Pharmacovigilance Inspections
October 14, 2014, EU Law and Life Sciences Webinar Series
January 9, 2014
LONDON, 9 January, 2014 — Covington & Burling advised Innovacell Biotechnologie AG on a collaboration and exclusive licensing agreement with Norgine BV. Under the terms of the agreement Innovacell and Norgine will co-develop, and Norgine will commercialise, ICEF15 - an innovative personalised cell therapy to treat faecal incontinence. The agreement territory ...
Practical Experience of the New Pharmacovigilance Legislation" and "In-house Counsel and Private Practice Panel Discussion: Regulatory Frameworks
May 14, 2013, Informa Life Sciences’ 22nd Annual EU Pharmaceutical Law Forum
Covington Receives Lex 100 Award
October 17, 2012
LONDON, 17 October, 2012 — Covington & Burling’s London office has been awarded a Lex Medal for “Confidence in being kept on” in the 2012/13 Lex 100 trainee survey. The Lex 100 is an online comparative guide to leading law firms aimed at those considering a career in law, based on the views of the trainees of the firms. Covington also scored especially highly ...
September 26, 2012, Inside EU Life Sciences
Originally published as Covington E-Alert on September 26, 2012 Today the European Commission published its long awaited proposals for the revision of the EU regulatory framework for medical devices. Three Directives, i.e., Directive 90/385/EEC on active implantable medical devices, Directive 93/42/EEC on medical devices and Directive 98/79/EC on in vitro ...
August 1, 2012, Inside EU Life Sciences
Originally published as Covington E-Alert on August 1st, 2012 On 17 July, the European Commission released the long-awaited proposal for a Regulation on clinical trials on medicinal products for human use (the Proposal). The future regulation will replace the Clinical Trials Directive 2001/20/EC, the revision of which has been advocated by the pharmaceutical ...
May 5, 2012, Inside EU Life Sciences
Originally published as Covinton E-Alert on May 25, 2012 On 16 May 2012, the European Commission adopted the much delayed list of permitted general health claims (Permitted List) for foods after scrutiny of the list by the European Parliament and the Council ended on 27 April 2012. The Permitted List contains just 222 health claims...… Continue Reading
Revision of the EU Legislation for Medical Devices and in vitro Diagnostics
April 19, 2012, Annual Conference on European Pharmaceutical Law 2012
March 19, 2012
LONDON, 19 March, 2012 — Covington & Burling LLP received 46 individual mentions and 20 practice mentions in the Chambers Global 2012 edition. The guidebook, which ranks lawyers globally by pan-regional and country practice area, is designed to identify the most skilled legal practitioners based on the qualities most valued by clients. The Covington lawyers ...
March 1, 2012, Covington E-Alert
Maintaining Robust and Effective Ongoing Compliance Training
June 30, 2011, Anti-Corruption for Pharma and Life Sciences Conference
June 15, 2011, Inside EU Life Sciences
Originally published as Covington E-Alert on June 15, 2011 The U.K. Department for Business, Innovation and Skills (BIS) has recently issued the final version of its guidance on the Agency Workers Regulations 2010, which implement Directive 2008/104/EC. The Regulations come into force on 1 October 2011, and will entitle agency workers (or “temps”) to the...… ...
June 15, 2011, Covington E-Alert
Update on the Current Legal and Compliance Challenges for the Medtech Industry
May 18, 2011, EU Pharmaceutical Law Forum 2011
May 9, 2011, Inside EU Life Sciences
Originally published as Covington E-Alert on May 9, 2011 The EU Court of Justice just issued two long awaited rulings on the interpretation of the rules governing advertising of medicines in Europe. They address (i) the requirement that all advertising must comply with the prescribing information (SmPC) for the product and (ii) the distinction between...… ...
May 9, 2011, Covington E-Alert
February 15, 2011
WASHINGTON, DC, February 15, 2011 — For the seventh time, Practical Law Company has awarded Covington & Burling LLP its worldwide first place ranking in the Life Sciences Regulatory Super League category. PLC also singled out Covington’s Antitrust/Competition, Corporate, and Insurance practices, along with lawyers from each group, in its practice-specific ...
November 30, 2010, EuroWatch
November 10, 2010, Covington E-Alert
September/October 2009, RAJ Devices
Covington Advises Procter & Gamble on $3.1B Sale of Global Pharmaceuticals Business to Warner Chilcott
8/24/2009
NEW YORK, NY, August 24, 2009 — Procter & Gamble today announced the sale of its global pharmaceuticals business to Warner Chilcott Ltd. Covington & Burling LLP advised Procter & Gamble on the transaction. Procter & Gamble is a leading global branded products company, with one of the strongest portfolios of quality, leadership brands in consumer health and ...
12/11/2008
WASHINGTON, DC, December 11, 2008 — Salix Pharmaceuticals, Ltd. announced that it has acquired rights to crofelemer from Napo Pharmaceuticals, Inc. Covington & Burling LLP represented Salix in the deal. Crofelemer currently is being investigated in a Phase 3 study as an anti-diarrheal agent for the treatment of chronic diarrhea in people living with HIV. Salix ...
11/15/2008
LONDON, 15 November, 2008 — The latest editions of Chambers UK and Legal 500 UK have recognised the London office of Covington & Burling LLP in a combined 22 categories, praising the firm’s lawyers for “best-in-class business acumen” and “excellent industry knowledge” as well as “consistent, absolutely top-tier service.” The firm’s London office has also ...
March 2008, EURALex
Covington Advises Encysive on Pfizer Deal
2/21/2008
WASHINGTON, DC, February 21, 2008 — Encysive Pharmaceuticals Inc. announced yesterday that it has entered into an agreement to be acquired by Pfizer Inc. Under the terms of the agreement, Pfizer will make a cash tender offer for all issued and outstanding shares of Encysive for $2.35 per share, representing an equity value of approximately $195 million. ...
November 20, 2007
LONDON, November 21, 2007 - This autumn Chambers and Legal 500 UK have recognised the London office of Covington & Burling in a combined 20 categories, praising the firm’s experts for “creative and commercial thinking” and “outstanding expertise” as well as “diversity of skills.” The firm’s London office has also achieved seven individual rankings and a further ...
October 2007, EURALex
8/7/2007
LONDON, 7 August, 2007 — Covington & Burling LLP announces its role in advising US biotechnology company Northwest Biotherapeutics, Inc. on its admission to AIM and £15 million placing, which valued the company at approximately £68 million on a fully-diluted basis. The transaction was particularly complex due to Northwest's quotation on the OTC Bulletin Board in ...
December 14, 2006, Covington E-Alert
November 15, 2006
LONDON, November 15, 2006 — This year’s editions of Chambers UK and Legal 500 UK recognize the firm’s expertise in eighteen areas, as follows:CHAMBERS UKCorporate Finance, Mid-Market, Best of the UK Life Sciences, London Product Liability, Food, London Product Liability, Mainly Defendant, Best of the UK In addition, the following individuals were ranked:Grant ...
Covington Announces Ten New Partners
10/5/2006
WASHINGTON, D.C., October 5, 2006 — Covington & Burling LLP announced the election of ten new partners, effective October 1. Stuart Stock, chair of the firm’s management committee, commented, “These remarkable lawyers reflect the strength and diversity of our firm and its practice. We are very pleased to have them as members of our partnership.” Covington’s ...
- LMG Life Sciences Europe, Life Sciences Star - Regulatory (United Kingdom) (2014-2015)
- Chambers UK, Life Sciences: Regulatory (2009-2020)
- Chambers UK, Life Sciences (2014-2018)
- Chambers UK, Product Liability - Food (2013-2014)
- Chambers Europe, Life Sciences (2015, 2017-2019)
- Chambers Global, Life Sciences (2011-2018)
- Super Lawyers - London, Administrative and Public Law (2013)
- Who's Who Legal, Life Sciences (2011-2017)
- Legal 500 UK, Pharmaceuticals and Biotechnology (2008-2016)
- Legal 500 UK, Product Liability, Defendant (2013-2016)
- PLC Which Lawyer?, Life Sciences, Regulatory (2008-2012)
- Legal Experts UK (2010)