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Simon H

Simon H

General Counsel/Senior Legal Consultant

Overview of Experience

I am an internationally experienced, English-qualified solicitor, working as in-house counsel with over 30 years of experience, both in major London law firms and working in-house within the life science sector, including:-

  • Merck Sharp & Dohme/Agvet.
  • Johnson & Johnson.
  • Eli Lilly and Company/Elanco.
  • Merck Group.
  • Gilead

Areas of Expertise

  • Bio-pharma.
  • Medical Devices.
  • In-Licensing.
  • Patent & general litigation.
  • Investigations & internal enquiries.
  • Sector enquiries (including the SFO and the European Commission).
  • Intellectual property.
  • Commercial transactions (including acquisitions and disposals).
  • Supply chain management & distribution.
  • Clinical trials

 

Therapeutic Areas

This includes Oncology, Fertility, Neurology, and Immunology, diabetes and bio-medicines.

Regulatory Jurisdictions

UK, Europe, U.S., Russia-CIS, Africa, Middle East, Turkey, Africa, LATAM, South-East Asia and PRC.

Track Record

At Merck Serono, I was responsible for all matters in the geography, across all therapeutic areas (oncology, fertility and neurology, immunology), including sales and marketing (including digital and patient support programmes), communications, HTA/NICE, clinical trials, contracting, real property, ethics and compliance, employment, data privacy (GDPR), materials transfer.

At Eli Lilly I was responsible for managing all legal aspects related to sales and marketing, clinical trials, quality control, company secretarial duties, contracting, manufacturing, and animal health. I lead a team of three lawyers and two compliance staff members.

I set up the agency distribution model in the UK, supporting the business through distributors and tenders in the UK, Ireland, and other locations. My role encompassed competition law matters, including EU Sector Inquiry, parallel trade, and general business practices as well as defending the company against generic competition.

I established the Ethics and Compliance function for the company in the specific geographic area and rolled out and managed the anti-corruption program.