Overview
Dominic Morega is Managing Associate and co-heads the firm’s Pharmaceutical, Biotechnology and Medical Devices practice group, being recognised as an outstanding and reputable lawyer in this niche area. He has a wealth of experience in pharmaceutical, healthcare and medical devices law, as well as corporate and commercial, mergers and acquisitions and dispute resolutions, notably in the life sciences sector.
Dominic has advised major international manufacturers of medicines, medical devices, food supplements, biological and chemical products or local affiliates thereof on a wide a wide range of projects, from setting up their subsidiaries or business takeover from local distributors, to various and complex regulatory, compliance, commercial and litigation matters. Dominic Morega has been actively involved in various regulatory projects concerning medicine related pricing, reimbursement, ethic conduct and taxation, by providing valuable input on certain pharmaceutical and medical devices project enactments or codes of ethics of the industry.
He has also been involved in several mergers and acquisitions in the pharmaceutical and medical services fields, his expertise covering the entire transactional process, from coordination of the due diligence work, assistance in the preparation or negotiation of the transaction documents, to closing and post-closing implementation matters.
Dominic Morega is a regular author of various articles on medicine and healthcare matters, as well as speaker on pharmaceutical law topics.
He speaks English fluently and is a Certified Expert in Public Procurement, accredited by the Romanian competent authority.
Relevant Matters:
- Co-coordinator of the legal team retained by some of the largest international medicine manufacturers based in the US, Switzerland, Germany and Japan or their local affiliates in the regulatory and negotiation proceedings with the Romanian health authorities, which have been successfully finalized by the execution of relevant cost-volume (managed entry) agreements for several innovative medicines or the unconditional inclusion of the INN in the official list of reimbursed medicines.
- Co-coordinator of the legal team assisting one of the largest US-based medicine wholesalers on the local loop of its USD 6.47 billion acquisition of another global wholesaler’s pharmaceutical distribution business in Europe together with other specified services, as well as retail pharmacy operations in several European countries.
- Successful assistance and representation of the marketing authorisation holders and the local affiliates within one the largest international pharma group based in Switzerland in several administrative and tax disputes, of several million RON each, concerning the clawback tax notified by the National Health Insurance House and the tax deductibility of marketing and promotion services, respectively.