A responsible role
The SMEC (Swissmedic Medicines Expert Committees) are made up of the VMEC (Veterinary Medicines Expert Committee) and the HMEC (Human Medicines Expert Committee). Both committees support Swissmedic in the scientific assessment of documentation relating to the authorisation, market surveillance and approval of medicinal and transplant products and medical devices. The HMEC consists of nine ordinary and, currently, 37 extraordinary members, plus seven advisory members. The number of extraordinary and advisory members is not restricted and depends on the need for specialist knowledge. Collaboration with external experts is an essential element at Swissmedic for ensuring the quality of the decisions that are taken. Appointed by the Swissmedic Agency Council for a four-year term of office, the external experts possess documented professional qualifications in medicine, pharmacy or science and experience in the clinical environment.
“I have 40 years' experience with clinical trials and am happy to continue offering my expertise.”
Thomas Cerny has been advising Swissmedic for over ten years and, for the past two years, has been an ordinary expert on the HMEC Board. How did this commitment come about? "A great many developments have taken place in oncology since the turn of the millennium. Dossiers for new authorisations or extensions of oncology products are constantly on the rise – Swissmedic asked me to help. I have 40 years' experience with clinical trials, particularly Phase 1 trials. Since I was very happy to offer my expertise, I immediately agreed", explains Cerny. The oncologist has worked in academic research since the 1980s, experienced the development of molecular biomedicine and been involved in the development, authorisation and optimisation of new medicines. As a former chief physician for oncology/haematology at St. Gallen Cantonal Hospital and a longstanding President of Swiss Cancer Research, Cerny has first-hand knowledge of the research scene and the concerns of patients and pharmaceutical companies. Thanks to his expertise in this area, he is highly valued at Swissmedic as an HMEC member.