Highlighted

The work of the HMEC The Expert Committee

In scientific questions concerning the authorisation of medicinal products, Swissmedic obtains specialist advice from experts. Where human medicines and people's health are concerned, the Swiss Agency for Therapeutic Products is supported by the HMEC. In recent years, oncology drugs (medicines for the treatment of cancer) have been the subject of particular focus. An expert in this field is Professor Emeritus Thomas Cerny MD – the renowned oncologist spoke to "Visible" about his work as a member of the HMEC.

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.

Focus on oncology drugs

Biomedicine has undergone a kind of revolution in the past 20 years: The focus has increasingly shifted to personalised medicine, where treatments are adapted to certain features of the patient based on the results of molecular genetic tests*. "This means that, in addition to the specific clinical presentation, individual molecular signatures and other patient-specific factors are taken into account when prescribing targeted medicines", explains Thomas Cerny. As a result, many precisely targeted drugs these days are submitted very quickly and on the basis of little clinical experience. The oncologist continues: "On the one hand, we don't want to withhold these medicines from seriously ill cancer patients, but on the other we often have few pointers concerning side effects and long-term safety – it's a balancing act." Patient safety is given top priority in authorisation. But in the field of cancer drugs, life-threatening situations are common, and it's more difficult to find a balance between benefit and harm. In recent years, the number of authorisation dossiers for oncology products has increased sharply. Nowadays, almost 40 percent of all the dossiers discussed by the HMEC Board involve medicines for treating cancer, and the trend is rising.

*Thanks to molecular biological tests, changes in DNA (genetic material) can be detected or ruled out

Decision-making process

Whether a medicine is ultimately authorised is decided by Swissmedic. The HMEC is the advisory committee. The primary role of the HMEC is to draw up recommendations to approve or reject a new medicinal product or additional indication. But HMEC members can also produce individual expert reports that address specific issues arising from Swissmedic's in-house reviews. The experts can also assume responsibility for the complete evaluation of authorisation dossiers.

“The authorisation of medicines is often a balancing act these days.”

What is the procedure for an HMEC meeting? The HMEC usually meets once a month. The agenda items are prepared by Swissmedic. "During the general part at the start of the meeting, we discuss new reports on medicines, for example concerning side effects that have occurred in a certain group of patients", according to Cerny. Topical health policy issues relating to authorisation can also be discussed. Thomas Cerny continues: "We then deal with the submissions. The Swissmedic in-house reviewer first explains the regulatory aspects, the position of Swissmedic and the critical factors in the dossier. Next, the HMEC expert presents his or her second opinion, and all unresolved issues are discussed collectively, resulting in a consolidated committee recommendation on the authorisation decision. Finally, the President of the HMEC sums up and formally dictates the established position." This minute-taking aspect is important because it clearly documents the decision-making process. After authorisation, the medicines must be closely monitored and new data subjected to continuous analysis. "It may be that a medicine is authorised and works, but is subsequently discovered, on the basis of new findings, to promote adverse effects, such as the formation of secondary tumours", explains Cerny. For this reason, the marketing authorisation holders may be asked to provide regular updates in order to monitor the long-term effect of the drug. Continuous and critical monitoring is extremely important in such situations.

“In some cases, there may be minor aspects that are not optimised – but, when it comes to treating patients, every detail counts.”

When is a medicine rejected? There are various reasons: for example, the data may indicate poor quality, or the studies are conducted in countries with inadequate health systems and, consequently, are not meaningful. Alternatively, the study design may be unconvincing from the methodology standpoint – although the drug may have a demonstrable effect, this might not be clinically relevant because the study lacked an appropriate comparator. "Since the dosage regimen or dose-finding process is also regularly found to be inadequate, we are unable to issue a positive decision on authorisation. In some cases, there may be minor aspects that are not optimised – but, when it comes to treating patients, every detail counts", stresses the oncologist.

General elections

The four-year cycle of the SMEC expires at the end of this year, and general elections for the 2021-24 term of office are imminent. Swissmedic is looking for suitable candidates to further strengthen the subject-specific expertise of the committees. Thomas Cerny has already declared his willingness to continue advising Swissmedic for a further four years as an HMEC member – welcome news.

In the next issue of "Visible", veterinarian Dr. Barbara Katharina Knutti presents the work of the Veterinary Medicines Expert Committee (VMEC).