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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.
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 ...
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 ...
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 ...
August 9, 2017, Covington Digital Health
On 28 June 2017, Advocate General Sanchez-Bordona (AG) presented his opinion in case C-329/16 Syndicat national de l’industrie des technologies médicales and Philips France following a request for preliminary ruling from the Conseil d’État (France) to the Court of Justice of the European Union (CJEU) concerning the laws governing the classification of software ...
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 ...