julia gillert

Julia Gillert

Of Counsel
Baker & McKenzie Services Limited

Biography

Julia joined Baker McKenzie's London office as a trainee in 2005, qualifying in 2007, with a secondment to the Singapore office, and has shaped her practice to focus exclusively on regulatory matters affecting the Healthcare & Life Sciences industry.

Practice Focus

Julia is a key member of the Firm's Healthcare Practice Group, at the London, EMEA and global level. She advises both domestic and international companies in the medtech, pharma and healthcare sectors on a wide range of regulatory and general compliance matters including industry code compliance, interactions with healthcare professionals and patients, genetic testing, clinical research, virtual health, CQC registrations, market access, biological products, patient support programs, digital health applications, borderline products, pre-licence communications, CE marking, marketing authorisations.

Julia sits on the Legal Committees of the Association of British HealthTech Industries and the Association of the British Pharmaceutical Industry, and is a spokesperson for the Firm on healthcare issues arising in connection with Brexit.

Representative Legal Matters

  • Advising global pharmaceutical companies and multinational medical devices manufacturers on a range of regulatory issues including advertising and promoting medical and healthcare products, approvals and market access including for biologicals and biosimilars, clinical investigations, CE marking and MAs, pricing and reimbursement, innovative market access arrangements, NHS records and data, human tissue regulation, as well as general regulatory compliance.
  • Advising a global tech company on the likely regulator treatment of various new consumer product permutations at the borderline of medical device regulation.
  • Advising a major US innovative medical devices and testing services company on navigating the UK regulatory and reimbursement regimes for a novel product and service.
  • Advising on the regulatory issues, including in particular, those arising upon the changes of manufacturer, involved in Baxter's spin-off of its biopharmaceutical business to Baxalta  in over 100 jurisdictions.
  • Advising various innovative laboratory testing service companies - oncological and genetic - on navigating the EU regulatory and UK healthcare regimes.
  • Advising specialist technology companies on entering the regulatory regime covering medical devices, including in light of the new EU Regulations.
  • Providing specialist regulatory support and advice on corporate transactions involving pharmaceutical, medical devices and healthcare companies.
  • Advising a number of companies on various projects involving the provision of health advice remotely, using a variety of telemedicine technologies.
  • Advising CareFusion on the divestment of its International Surgical Products business based in Switzerland, with operations in 16 European and Asia-Pacific countries for $130 million.
  • Advising Cardinal Health on the divestment (share sale by auction) of Martindale Pharma, a UK and Germany based manufacturer and supplier of pharmaceuticals to AAC Capital Partners Limited.
  • Advising a multinational innovative agriculture company on the UK integration of its recently acquired multinational seeds company.
  • Coordinating advice for a multinational medical devices manufacturer on pricing and reimbursement systems internationally.
  • Advising a pharmaceutical and medication delivery company on the UK part of its global restructuring and integration of a recently acquired pharmaceutical company.
  • Advising a multinational healthcare research company on its UK clinical trials.
  • Co-ordinating a multijurisdictional co-promotion and co-marketing survey in order to advise a US research company with product licence rights for Europe.
  • Advising numerous healthcare companies on the CQC regulatory landscape for the provision of healthcare in hospital and clinic settings, in the home and on a virtual basis, including in relation to online prescribing and ehealth.

Professional Associations and Memberships

  • Law Society of England and Wales - Member
  • Legal Issues Committee, Association of British HealthTech Industries - Member
  • Legal Community of the Association of the British Pharmaceutical Industry - Member

Admissions

  • England & Wales~United Kingdom (2007)

Education

  • Nottingham Law School (L.P.C.) (2004)
  • Nottingham Law School (Graduate Diploma Law) (2003)
  • University of Nottingham (B.A. English Honors) (2002)

Languages

  • English

Julia has contributed to all the Baker & McKenzie healthcare publications from a UK perspective, co-edits the Firm's European Healthcare Newsletter, regularly speaks at industry events, and is a contributor to journals MedTech Insight and Scrip Pharma Intelligence, as well as to LexisNexis.