7 June 2022: Rawlins - A

Sir Michael Rawlins was a student in the 1960s, but he doesn’t appear to be a child of that swinging decade; although unusually he is giving his evidence from a well-padded leather couch (probably from his own home). His ‘60s drug focus was on Aspirin – hardly a psychedelic. His later senior roles involved him in ethics related to the use of medicines, the misuse of drugs, and the safety of medicines. He is the person who originally set up NICE. Pharmacovigilance was quickly explained as being about both safety and efficacy.

His chairmanship of these senior Government roles came as a result of a “tap on the shoulder”. These posts were never advertised. There were some processes involved in approving appointments, but there was no strict rule about checking for any conflicts of interests, other than expecting people to be honourable and make a statement for themselves. Training was never offered to the witness, and he thought that was normal. Remembering that these were key roles in health safety and oversight, the lack of priority given to ensuring and maintaining competence or checking conflicting interests was such a British way of doing business. Apparently, it was sufficient if someone thought you were a “good egg”.

Papers for meetings came in “blue bags” which he took home at the weekend to read then lugged them back to London for the meetings. There was no salary, but expenses were paid. There was also no formal continuing professional development imposed. It was just expected that committee members would keep themselves up to date with new research and practice.

The Committee on the Safety of Medicines (CSM) advised the licencing authorities on safety, quality, and efficacy, including the monitoring of adverse reactions, and issuing warnings about hazards. These warnings were often communicating through their “little magazine thing”, occasionally backed up by a “Dear Dr” letter, such as from the Chief Medical Officer (CMO). There were annual reports to Ministers, and when these were published, they were made available for sale. The Medicines Division had 232 staff, who had a range of clinical and professional expertise, along with administrators, and four lawyers. Part of the Department’s role was to oversee issues related to defective batches of an otherwise approved medicine. Licencing paperwork and records were considered to be legal documents. Counsel pointed out the cyclical system of originating and advising on medicines. The witness could not remember any cases of any advice being rejected. There was a “black triangle” process for medicines under explicit monitoring processes. Clearly, the system was set up with what appeared to be sufficient checks and balances, including an appeals process, but it was all very “in-house”. 

Some time was given to examining the confidential way of protecting the discussions within the meetings. Some consideration was given to disclosure and increasing transparency about the inner working of the medicine safety mechanisms. This was happening in the context of the emerging Freedom of Information push. The need for confidentiality did not appear to be imposed rather but assumed as the way of working. (How civil-servanty is that?) He did remember having to engage with the secrecy process. A key role was to ensure dissemination of the knowledge of contra-indications, warnings, and precautions, for example, to be included in Patient Information Leaflets. There was no known prevention of committees seeking external expert advice, other than how it related to the issue of preserving confidentiality.

A lot of the research to back up the need to ensure quality, efficacy, and safety was through animal research. “Safety is a balancing act” says the witness. As required, the positive effect of a medicine might open up some allowance for adverse reactions if it was judged that overall, the benefits outweighed the hazards or actual side-effects. It was a risk/benefit judgement call. After Counsel went through the process of describing the production of adverse reactions notices, the witness could not remember them. “Current Problems” was an occasional publication, including references to the “Yellow Card” system. From this writer’s memory of the BNF reference book held as a bible by many doctors, it would seem important to ensure these supplementary adverse reactions and problems publications should be kept together. Occasionally, one of the Dear Dr letters would be “leaked to the press”, but that was the extent of letting the public know of the workings and outputs of the medicines safety activity “in those days”.

With his thin face and jowls behind large round glasses, his frequent forward leaning position due to the positioning of the monitors through which the witness is engaging with the Inquiry, and the typical elderly gentleman’s open mouth expression is topped off with his precise received pronunciation. Occasionally, his concentrated screen time efforts are relieved by periods of sitting back in the enfolding arms of the cushioned couch, with an uncharacteristic propping up of a foot on the table where the screens were sitting.