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Sarah Cowlishaw is a partner in the Life Sciences group, whose practice focuses on life sciences regulatory and commercial law.
Ms. Cowlishaw advises major national and multinational pharmaceutical companies and biotechnology, diagnostic, medical device, and consumer product manufacturers on a wide range of regulatory, compliance, transactional and legislative matters. Her advice on general regulatory matters includes borderline determinations, adverse event and other reporting obligations, manufacturing controls, and labeling and promotion.
On the commercial side, she advises on the full range of agreements that span the product life-cycle in the life sciences sector. Her expertise includes clinical trial agreements, manufacturing and supply agreements, distribution and other marketing agreements and regulatory services agreements.
Ms. Cowlishaw has particular experience in digital health matters from both a regulatory and commercial perspective. Ms. Cowlishaw speaks regularly on subjects such as medical device regulation and digital health.
- Regulatory and commercial advice on digital health and health information issues to clients in the life sciences and software technology industries.
- Regulatory advice on product classification issues, including the borderlines between medicines, medical devices, cosmetics and combination products.
- Regulatory and commercial due diligence for pharmaceutical, medical device and food companies.
- Negotiation and review of life sciences commercial arrangements, including clinical trial agreements, wholesaler arrangements and pharmaceutical manufacturing and supply contracts.
- Participation in compliance-related investigations and initiatives in respect of alleged breaches of medicines advertising, anti-bribery, clinical trials, and pharmacovigilance rules.
- Co-ordinating international projects on advertising/promotion and clinical research.
Pro Bono
- Advising the Restoration of Appearance and Function Trust (RAFT) on the classification of a wound healing product containing human blood derivatives.
- Assisting in a pro-bono project aimed at improving regulatory systems for clinical trials of drugs and vaccines for neglected diseases in developing countries.
Previous Experience
- Secondment to the in-house legal department of a multinational pharmaceutical company.
- Secondment to the in-house legal department of an international pharmaceutical company, based in Germany.
March 29, 2020, Covington Alert
Medical device manufacturers are facing numerous novel legal, regulatory, and commercial issues as a result of the evolving COVID-19 public health emergency. This slide presentation addresses key regulatory considerations for medical device companies seeking to supply products that are in critical need, including the Emergency Use Authorization pathway and other ...
March 25, 2020, Inside EU Life Sciences
The European Commission has announced today that it is working on a proposal to postpone the application date of the Medical Devices Regulation 2017/745 (“MDR”) for one year. This proposal is to relieve the pressure on national authorities, notified bodies, manufacturers and other actors so they can focus on responding to the COVID-19 outbreak. According...… ...
March 25, 2020, Covington Digital Health
On 23 March 2020, the Department of Health and Social Care (“DHSC”) issued a plea to technology companies to come up with digital support solutions for COVID-19. The DHSC is making £500,000 available, with funding of up to £25,000 per company. The challenge, named TechForce19, aims to increase community support for the elderly, vulnerable and...… Continue ...
March 25, 2020, Inside EU Life Sciences
On 23 March 2020, the Department of Health and Social Care (“DHSC”) issued a plea to technology companies to come up with digital support solutions for COVID-19. The DHSC is making £500,000 available, with funding of up to £25,000 per company. The challenge, named TechForce19, aims to increase community support for the elderly, vulnerable and...… Continue ...
March 23, 2020, Inside EU Life Sciences
The Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a specification for a “Rapidly Manufactured Ventilator System” (“RMVS”), setting out the clinical requirements for a ‘minimally acceptable’ ventilator for use in hospitals during the COVID-19 outbreak (the “RMVS Specification”). The purpose of the RMVS Specification is to meet the UK ...
March 18, 2020, Covington Alert
To assist companies that are developing technology solutions to help predict, mitigate or contain the spread of COVID-19, our cross-practice digital health team has put together a checklist of considerations to keep in mind. For additional guidance, please visit our COVID-19 Legal and Business Toolkit or reach out to us at COVID19@cov.com.
March 9, 2020, Covington Digital Health
In this final instalment of our series of blogs on the European Commission’s plans for AI and data, announced on 19 February 2020, we discuss some potential effects on companies in the digital health sector. As discussed in our previous blog posts (here, here and here), the papers published by the European Commission cover broad...… Continue Reading
Sarah Cowlishaw Named to The Lawyer “Hot 100”
January 28, 2020
LONDON—The Lawyer has named London life sciences partner Sarah Cowlishaw to its “Hot 100,” a list that recognizes the most daring, innovative and creative lawyers from in-house, private practice and the Bar around the U.K. The Lawyer highlighted Ms. Cowlishaw’s work for biotech company Sensyne Health on regulatory matters related to its AIM IPO and her ongoing ...
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 ...
January 2020
Covington has created a list of Top 10 Questions for Ideation of Digital Health Solutions that can help lawyers contribute to the digital health ideation process. Our clients increasingly apply agile product and business development methodologies when they are developing digital health solutions. "Ideation" is part of that process and involves the rapid ...
October 21, 2019, Covington Digital Health
The EU’s regulatory rules for medical devices are due to change on 26 May 2020, when the new Medical Device Regulation (“MDR”)[1] comes into effect. The regime for in vitro diagnostic devices will change two years later from 26 May 2022 when the In Vitro Diagnostic Devices Regulation (“IVDR”)[2] will apply. In advance of these...… Continue Reading
October 2, 2019, The American Lawyer
Covington Promotes Its Most Diverse Partner Class Ever
October 1, 2019
WASHINGTON—Covington has promoted to its partnership 14 lawyers based in eight different offices, including nine women and six lawyers of ethnically diverse backgrounds. “Our new partners are exceptionally talented lawyers from a wide range of the firm’s offices and most important practices, and they are extremely well-positioned to carry the firm forward,” ...
September 24, 2019, Covington Digital Health
Our clients increasingly apply agile product and business development methodologies when they are developing digital health solutions. “Ideation” is the part of that process and involves the rapid identification and creation of ideas for digital health solutions, which are then prototyped and tested. Covington has created a Top 10 Questions for Ideation of ...
August 21, 2019, Covington Digital Health
On 13 August 2019, the European Commission opened a call for expression of interest to relaunch the eHealth Stakeholder Group with a view to supporting the “digital transformation of healthcare in the EU”. The eHealth Stakeholder Group was first launched in 2012 and in its first iteration (between 2012 and 2015), contributed to the development...… Continue ...
August 9, 2019, Inside EU Life Sciences
France’s medicines regulator, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), has released draft guidelines, currently subject to a public consultation, setting out recommendations for manufacturers designed to help prevent cybersecurity attacks to medical devices. Notably, the draft guidelines are the first instance of ...
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.
July 24, 2019, Covington Digital Health
France’s medicines regulator, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), has released draft guidelines, currently subject to a public consultation, setting out recommendations for manufacturers designed to help prevent cybersecurity attacks to medical devices. Notably, the draft guidelines are the first instance of ...
UK’s NICE releases newly updated Digital Health Technologies (DHT) Evidence Standards Framework
March 19, 2019, Covington Digital Health
Following on from the Evidence Standards Framework for DHTs published in December 2018 (the Original Standards, as reported in our previous blog post, here), the UK’s National Institute for Health and Care Excellence (NICE) recently published a newly updated version of the standards (the Updated Standards, available here). The Updated Standards were produced ...
February 25, 2019, Covington Digital Health
On 15 February 2019, the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) published their Joint Big Data Taskforce’s summary report (available here) setting out recommendations for understanding the acceptability of evidence derived from ‘big data’ in support of the evaluation and supervision of medicines by regulators. The Taskforce has ...
October 15, 2018, Covington Digital Health
On 8 October, the European Medicines Agency (EMA) published a report (available here) setting out the progress it has made towards applying a common data model (CDM) in Europe. The EMA defines a CDM as “a mechanism by which raw data are standardized to a common structure, format and terminology independently from any particular study...… Continue Reading
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 ...
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 ...
March 17, 2017
LONDON—Covington advised AstraZeneca on its strategic collaboration with Circassia Pharmaceuticals plc, a respiratory biopharmaceutical company, for the development and commercialisation of Tudorza and Duaklir* in the U.S. Tudorza and Duaklir are inhaled respiratory medicines for the treatment of chronic obstructive pulmonary disease (COPD). Tudorza was ...
October 21, 2016
WASHINGTON—Covington represented India-based Piramal Enterprises and its wholly owned Critical Care subsidiary in the UK in the acquisition of five anesthesia and pain management injectable products from Janssen Pharmaceutica NV, in an all cash deal for an upfront consideration of US$155 million, and up to an additional US$20 million. The products to be acquired ...
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 ...
June 12, 2015, Inside EU Life Sciences
The European Medicines Agency (EMA) has recently published for public consultation its draft guideline on clinical development of fixed combination medicinal products (Draft Guideline), which is intended to replace CHMP/EWP/240/95 Rev. 1 (Existing Guideline). The Draft Guideline applies to fixed combination medicinal products containing two or more active ...
February 27, 2015
LONDON, February 27, 2015 — Covington advised Heptares Therapeutics Limited on its announced sale to Sosei Group, a Tokyo-listed Japanese biopharmaceutical company with operations in Japan and the UK. Consideration consisted of $180 million cash at closing and up to an additional $220 million contingent upon the successful progression of Heptares’ pipeline and ...
August 7, 2014
LONDON, 7 August, 2014 — Covington advised Ergomed plc, an international clinical research business, on its flotation on the AIM market of the London Stock Exchange, an associated fundraising and its simultaneous acquisition of PrimeVigilance Limited, a leading provider of pharmacovigilance and medical information services. Ergomed ‘s market capitalisation on ...
August 5, 2014
LONDON, 5 August, 2014 — Covington & Burling advised Illumina on its partnership with Genomics England to provide infrastructure and expertise for a four-year project that aims to make the UK the world leader in genetic research into cancer and rare diseases, through funding research to decode 100,000 human genomes - a patient's personal DNA code. The deal is ...
December 5, 2013, Inside EU Life Sciences
On 25 November 2013, the European Commission published an Implementing Decision containing guidelines to assist responsible persons comply with their regulatory obligations under the EU Cosmetics Regulation (EC) No 1223/2009 (Cosmetics Regulation). The guidelines provide clarity on Annex I of the Cosmetics Regulation, which sets out the minimum requirements for ...
June 12, 2013, Inside EU Life Sciences
On May 30, 2013, Advocate General Sharpston delivered an opinion on a request for a preliminary ruling from the Finnish national courts concerning the laws governing reclassification of medical devices (Advocate General: Opinion, Case C-109/12). The Advocate General’s opinion does not bind the Court of Justice of the European Union (CJEU). However, in the ...
What’s in a Name?
September 5, 2012, Inside EU Life Sciences
Article originally published in European Pharmaceutical Contractor, September 2012 Although at first sight the rules that govern the distinction between medical devices and medicines in the EU allow for a direct and systematic approach, borderline determinations are, in practice, often difficult and the rules lack logical rigour The European Commission is ...
- The Lawyer, "Hot 100" (2020)
- 50 Movers and Shakers in BioBusiness (2019)
COVID-19: Legal and Business Toolkit
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