Professional regulation – a DIY job?
pharmafile | May 2, 2012 | Feature | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | CPD, GMC, Les Rose, drug discovery, regulation
What would happen if we had no drug regulatory bodies, such as the MHRA and the EMA? Can you imagine the pharmaceutical industry putting up a cogent case for self-regulation of drug development?
No, I thought not. Yet that is what goes on in various critical areas of human activity. Think about lawyers. They are regulated by The Law Society, which represents the interests of lawyers, as well as regulating their activities.
I don’t think you will say that reaching correct legal decisions is far less important than having safe and effective medicines. So why are lawyers allowed to regulate themselves? Rather more relevant to us in the healthcare field, is the General Medical Council.
Wearing two hats
Rather like The Law Society, the GMC has traditionally combined two roles, that of representing the interests of medical doctors, and regulating them. It is surprising that this potential conflict of interest has only recently been recognised.
In my limited experience of both bodies, the regulatory role has appeared to be weaker than it might have been. Hence, there is a move to separate the two functions. If you have any spare time, you might be amused to read the transcripts of some GMC Fitness to Practise hearings. The proceedings can appear rather theatrical.
The case is ostensibly brought by the GMC against the doctor, so a barrister acts for the GMC in presenting the case for disciplinary action. But the GMC also appoints the Fitness to Practise panel, as well as investigating the case.
As I say, the conflicts of interest inherent in this situation have been recognised, and changes to the Fitness to Practise to be introduced this year will separate the functions and hopefully lead to greater impartiality. At the same time, oversight of GMC decisions is likely to be strengthened, to enable the public to challenge them more effectively when they appear to be unjust.
Sham regulation
But other regulators lag a long way behind. In 1994, chiropractors and osteopaths became regulated by law. I should not set these practitioners alongside physicians as equals in healthcare.
Chiropractic is a very narrow specialism, with only weak to moderate evidence of effectiveness for low back pain, and no solid evidence for anything else. Evidence for osteopathy is slightly more robust. The saga of the British Chiropractic Association and its claims for efficacy in various infant conditions (e.g., colic, bed wetting, and persistent crying) has been very well aired in the medical and lay media over the last 2-3 years.
Partly as a result of that, The General Chiropractic Council received a few hundred complaints about the claims that practitioners were making on their websites. Most of them were let off, without even a caution, and the reason for that defies logic. In effect, the GCC said that it had itself issued a leaflet to registrants which included certain claims, one example being sciatica.
The GCC on reflection agreed that there was no evidence that chiropractic helps sciatica, but that as the practitioners were only following GCC policy, they could not be held responsible. Can there be no better example of the futility of self-regulation, as well as of the Nuremberg Defence (‘I was only following orders’).
CPD – keeping up-to-date
But let me digress for a moment to consider one form of voluntary regulation that has burgeoned in recent years – Continuing Professional Development. Well I say it is voluntary, but in some cases it is in fact compulsory. Of course, doctors have to complete a certain minimum of CPD points to maintain their registration, and rightly so. Medicine is a fast-moving field, and especially therapeutics as a key part of it.
Some might argue that there have been fewer really innovative drugs recently, especially over the last 10 years, but much more important is the development of the knowledge base about drugs in particular and medicine in general.
What we thought we knew about healthcare can easily be overturned by newer and better research. Take the case of hormone replacement therapy. For years it was believed that, not only did it protect post-menopausal women against bone fractures, but that it reduced the risk of coronary heart disease. That belief was based not on a rigorously designed randomised controlled trial, but on an uncontrolled cohort study.
However, a very large RCT with over 16,000 women in it, subsequently found an increased risk of CHD in women receiving HRT. That does not sound the death knell for HRT as a whole, but it does change the risk:benefit assessment.
Now what if doctors and other healthcare workers were not required to keep abreast of such developments? Patients would be put at greater risk. Indeed, that used to be the case before CPD became the norm.
When I first entered the pharmaceutical industry, pharmacists would tell me that the doctors who made the most mistakes in prescriptions were the ones who didn’t see sales reps.
In the case of registered doctors, CPD is not really self-regulation, because if a doctor doesn’t keep it up they will lose their registration. That’s the law. In most other professions with CPD systems, you don’t automatically lose your job if you skip it.
However, it is still in the process of becoming established as a mark of professional competence. And such competence is certainly required to be demonstrated in drug development. Under prevailing regulations, anyone working on a clinical trial must be qualified by education, training and experience.
It’s normal for CVs and training records to be demanded by inspectors, so they always go into the trial master file. But experience is rather more difficult to establish. This is where the difference lies between a training record and a CPD record. The former itemises formal training, usually classroom or workshop style, while the latter is more inclusive.
It should include a wide range of experiential material, e.g., doing preparation and research for a new assignment or project, or reviewing the work of colleagues. Maintaining CPD can be quite onerous, even on a voluntary basis. With three professional bodies, and fellowships in two of them, I have to plan time just to keep the record up to date (well, in reality it is rarely up to date).
A critical look at competence
I promised to steer the discussion back to professional regulation. With my libertarian hat on (only worn once a week), I might resist further mandatory regulation within drug development.
But the success of projects depends critically on people, and especially on people knowing what they are doing. I don’t think that can be achieved by recruiting people from stacking shelves in a supermarket, training them for three hours in phlebotomy, and putting them to work in a phase I unit (a real example).
Finding a training record of that sort after the study has been completed is a horse long bolted, so what is needed is an understanding of what the competence standard really is.
I must confess that I am less than perfect at maintaining my CPD record, but part of that may relate to the fact that no employer or client has ever been interested in it. Yes, they ask for a training record, but all they want that to cover is company SOPs – and their company not anyone else’s.
It appears to me that competence is thus boiled down to an absolute minimum, so it can hardly be surprising if project performance barely reaches adequacy. So let’s fly a few kites into a sky where mediocrity does not live.
A new role for inspectors?
Neither self-regulation nor mandatory external regulation will be sufficient alone. Hitherto, drug regulators are seen as more of an obstacle to be overcome, than a partner in delivering treatments for unmet medical need.
Thus, regulatory inspectors are not looking for excellence, they are satisfied with basic competence. Perhaps this should change, and the game should be raised. A client once told me: “Quality is a moving standard”, and it’s true that we have to strive for continual improvement.
What if an MHRA inspection listed a number of observations regarding the competence of some of the study team, as evidenced by their training records? I say ‘observations’ because they would not be breaches of regulations, but they might indicate a racking up of standards.
Shouldn’t regulators work more closely with professional bodies so that expectations of competence, and how it is documented, are clearer?
I don’t want any of my many friends in the pharmaceutical industry to think that I’m condemning them as less than competent. But the best laid plans can come apart if just one aspect of one person’s ability is compromised, or simply not a good fit with the needs of the project.
If standards and expectations are clearer at the planning stage, that risk is reduced. Ideally, the project manager would like to be able to choose the ideal team members, but reality is not like that. They have to assemble a team from the people available, and then ensure they are capable of doing the work.
With more of a consensus as to what level of professionalism is expected, there might be a smaller chance of competence gaps arising.
Related Content
PeptiDream and Novartis extend peptide discovery collaboration
PeptiDream has announced the expansion of its peptide discovery collaboration with Novartis Pharma AG.
Allumiqs and Prolytix enter partnership for acceleration of drug discovery and development
Allumiqs and Prolytix have announced that they have entered into a long-term, strategic partnership with …
Isomorphic Labs to collaborate with Eli Lilly
Isomorphic Labs has announced that it has entered into a strategic research collaboration with Eli …
