The Medicines and Healthcare Products Regulatory Agency is a full-blown and unapologetic regulator in an era of deregulation. Winnie Agbonlahor hears its chief executive, Dr Ian Hudson, explain the value of its work
Most doctors have an inherent desire to help people – an enthusiasm that helps motivate them through their many years of training and study. And surely, the ability to cure the sick must do wonders for job satisfaction. But Dr Ian Hudson has found his niche in helping to cure the many, not in directly treating the few. After qualifying, he worked in various roles – predominantly in paediatrics – until he did a research fellowship at the University of Glasgow. It was during this period that the father-of-one realised how much he enjoys the research environment, he tells CSW.
“Through research,” he says, “I’ve been involved in the development of [medical] products that will affect the lives of many more millions of people than I would have if I’d had a life in clinical practice.” His fascination with medicines brought him to SmithKline Beecham – the precursor to today’s pharmaceutical giant GlaxoSmithKline – where he held various research and development posts, including that of acting medical director in Australia. But after 12 years, he decided to swap his private sector job for a role in government. In 2001, he joined the Medicines Control Agency – now part of the Medicines and Healthcare Products Regulatory Agency (MHRA), which these days Hudson heads up.
Since he joined the organisation, he hasn’t looked back. He describes the MHRA – an executive agency of the Department of Health (DH) – as a “very exciting place to be”, adding that “the 1,200 people [who work here] include many experts nationally and internationally in their fields, well respected for their contributions; we’ve got medics, pharmacists, toxicologists, scientists et cetera, all part of a very highly-motivated workforce. The variety of people I work with has actually been the biggest excitement for me in working with the agency.”
His calm and gentle demeanour and impeccable bedside manner offer a glimpse of Hudson’s past life as a professional doctor. He is clearly enthusiastic, too, but his enthusiasm is always modulated by his pragmatic and matter-of-fact personality. And as he talks, it becomes clear that his pragmatism is essential when managing an organisation as multi-faceted and complex as the MHRA.
The agency’s primary function is, as its name suggests, the regulation of medicines: everything from the medication used to treat and prevent illnesses – including non-medicinal prophylactics such as condoms – to other healthcare products including mobility scooters, wheelchairs and defibrillators.
If a company wants to bring a new medical product onto the market or conduct a clinical trial, it has to go through the MHRA’s licensing process and place its product under the agency’s ongoing scrutiny. This monitoring process involves risk-based inspections, and the collating of reports from both the public, and pharmaceutical or healthcare professionals. If a medicine has made it onto the market and problems are detected, MHRA communicates this to professionals and the public or, in some cases, orders the withdrawal of the medicine from the market altogether. It also tries to police the manufacture and sale of counterfeit drugs, and has the power to prosecute anyone breaking medicines regulation.
Flexible… to a degree
The MHRA operates as a trading fund, charging healthcare companies fees – and this, Hudson says, give it a degree of flexibility: the funding model has enabled the agency to grow its workforce in response to rising demand during the last decade.
In part, this changing demand reflects a changing regulatory regime, not growth in healthcare markets. In 2004, a new procedure was introduced by the EU Commission. The new ‘decentralised’ procedure means that if a company wants to obtain a licence to sell a drug in more than one EU member state, it can apply for a market authorisation to one national regulator, which then shares its findings with the other countries. If these other EU member states agree with the first state’s findings, they can simply concur and issue a licence for the drug in their respective countries.
As pharmaceutical businesses chose to seek licences from the MHRA rather than the European Medicines Agency, which centrally regulates drugs for the European single market, Hudson’s agency “grew rapidly by about 14%” – but demand has since ebbed, leaving him with cuts to make. In the context of this Parliament’s spending cuts, though, the MHRA appears to have got off relatively lightly: Hudson acknowledges that it’s only a “small correction”. He’ll have to find around £10m per year in savings, and plans to lose 125 posts over the next three-and-a-half years. “We will do that, as best we can, through natural turnover, and do our utmost to avoid any redundancies,” he comments.
There’s been one other cut in recent years: the MHRA’s medical devices regulatory budget, which is totally funded by DH, shrank from £12m to around £9m over the three years to 2013-14. But in general, Hudson is keen to emphasise that “we’re a pretty stable organisation”, adding that adapting the organisation’s size according to changing demand is “what a trading fund is designed to do”.
He has less flexibility around staff pay. To date, he says, the organisation has been able to attract and retain “an extremely experienced and well-qualified workforce”. But he admits that “it has been a difficult environment in the civil service, with several years of pay freezes”. Asked whether he’s worried there might be a risk that he’ll be unable to attract and retain the blend of skills required to safeguard public health, he responds: “Of course that’s something on our minds; we don’t have the same flexibilities as industry or the ability to pay some very high salaries.” Staff pay, he says, is “an area we need to be very careful about.”
With civil service pay being controlled centrally, how can his vigilance make any difference? “We have to look at the whole package of things that we offer,” he says. “So there is the salary and potential for bonuses as part of the civil service scheme, but we also support things like higher medical training in pharmaceutical medicine; leave is reasonable; the pension scheme is still pretty good, compared to a lot of outside organisations”. In any case, “it’s not just the single number of the salary” that attracts people to the MHRA. “It’s certainly true we’re unlikely to pay more here than industry, but the sheer fascination, the range of work that we deal with here is often very rewarding.”
Not just a regulator
Indeed, the MHRA is more than just a regulatory authority. Besides this main function, it also includes the National Institute for Biological Standards and Control (NIBSC), which sets biological standards. Just as the whole world agrees on how long a metre is, the NIBSC sets standards for units in biological products such as vaccines. It produces more than 90% of the world’s international biological standards, working with the World Health Organisation in order to ensure “the consistency of biological products”. After all, as Hudson explains, “when you receive a vaccine, you need to know what you’re getting – so you have a test to assay it”.
How has this Hertfordshire-based institute become the global lead on something as important as this? “It’s something that’s developed over the years,” Hudson says. “The NIBSC has been doing this for a long time, working with international colleagues for many years: it has been highly regarded, and made a major contribution to the quality of biological medicines”. It was founded in 1972, and receives around 60% of its revenue from the fees it charges for its services, including the sale of biological standards; the DH provides the remaining 40%.
The MHRA also runs the Clinical Practice Research Datalink (CPRD): a research project which collects and stores anonymised patient data from people in England for medical research. The CPRD was launched in April 2012, following on from its predecessor – the General Practice Research Database, which had been operational for 23 years. CPRD runs alongside the NHS Care.data scheme, which operates under the same model, but is compulsory for all GP practices; the CPRD is voluntary. While Data.care was recently paused, the CPRD project is, Hudson says, currently at “an investment phase, a growth phase, with DH and MHRA jointly investing in it”. So far, at least 1,300 studies have been carried out using the CPRD and its predecessor. Increasingly, he says, it is “a fantastic tool for healthcare research purposes to be able to address many questions as we go forward”.
So far, the database includes information on around a tenth of England’s population, and the aim is to grow this. But there is a concern among members of the public around the safeguarding of this data. The data undergoes stringent processes to be anonymised and is only given to ratified professionals, but certain fears remain. What if someone manages to match datasets against each other and thus de-anonymise patient records? What if this information somehow ends up in the hands of healthcare insurers?
Hudson is reassuring: “We’ve got a long track record. We’ve had over 20 years of GPRD, going into CPRD, and we are very conscious to ensure that all procedures that can be put in place are put in place. We only allow research in accordance with research protocols, and go through the independent scientific advisory committee. We take great care to ensure that any possible identifiers are not there, and that it’s properly anonymised data that goes to researchers. So we’re extremely cautious about that side of things; we make sure that all steps that can be taken are taken”.
One area where the MHRA doesn’t have such a long track record is in the regulation of electronic cigarettes. New legislation expected to come into force in 2016 will mean that companies producing e-cigarettes can apply for these to be regulated as medicine. Those companies choosing not to have their products so regulated will have to fulfil certain criteria on matters such as the amount of nicotine they contain.
With e-cigarettes currently easily available in corner shops, why would any firm decide to subject itself to the medical regulation processes? Currently, tobacco products are restricted in the way they can be advertised, Hudson replies. If e-cigarettes become licensed medicines – provided that the “manufacturer makes a claim about helping smoking cessation or harm reduction – then there may be some more freedoms there,” Hudson explains. These freedoms may also extend to areas such as “recommendations to use in the health service”, he adds. The prospect of stronger advertising rights and the establishment’s backing, he says, may encourage companies to apply to have their e-cigarettes regulated as medicines.
Last month, the MHRA also launched the Early Access to Medicines Scheme (EAMS), which aims to give patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation – meaning they aren’t fully approved – when there is a clear and unmet medical need. Under the scheme, the MHRA will provide a scientific opinion on the benefit and risk balance of the medicine, based on the data available at the time of the EAMS submission.
This all sounds rather risky. What if something goes wrong? “As with all medicine, it is important they are monitored carefully when used – particularly when it’s a little bit earlier in their development phase – so that if any new safety information becomes available and someone does suffer an adverse reaction to a medicine, that can be dealt with very promptly and action can be taken appropriately,” Hudson replies. Medical decisions must often be taken without all the information doctors would like, he says: the important thing is “to be clear about what is known and what is not known; the prescriber and patient will make a judgement.”
Dealing with problems
Even once a medicine has been licensed and used on patients, problems can still occur. As Hudson explains, with “any medicine that’s put on the market, you know a certain amount about it, but you never know everything about a medicine until it’s been on the market for many years”.
Doesn’t he ever worry that drugs he has allowed to be used will cause serious harm? The MHRA provides information on the risks of drugs that it’s licensed, he says: it’s for doctors and patients to make the decision whether to take those risks. The only thing the MHRA can do, Hudson says, is to “make sure that if someone has had a reaction, that we’re able to assess that reaction and, if necessary, communicate about it and consider the implications for the product; and then pass that on so others are aware.” Remember, he adds, that “medicines are being used to treat illnesses, and are not being taken by people who are entirely well. Clearly one’s tolerance of side effects is dependent on the nature of the illness”.
The red tape challenge
This government aims to reduce regulation and guidance. For a regulator, this must be a tricky challenge to meet. Not at all, Hudson responds: “We’ve done a lot in this area over the years, and have a very good track record. We’ve simplified our fees structure. We’ve consolidated the medicines legislation from lots of different pieces of legislation all into one.”
The process is ongoing, though, and the ultimate aim is to reduce guidance by some 40%. To help with this process, the MHRA has “a very active Medicines and Industries Liaison Group, where we discuss with industry areas that might be amenable to simplifying”. The MHRA’s analysis shows that so far, cutting red tape has led to £30m in industry savings.
If there is so much room to cut guidance and regulation, why was it ever there in the first place? “What has happened,” Hudson says, “is we ended up with some duplication of guidance or excessive guidance, and our plans are to streamline and simplify it as much as we can.” He reassures me that as “things move on, there is no way that we plan to do anything that will harm public health – but we can do some things a bit smarter.”
Hudson is clearly very proud and enthusiastic about the organisation he leads –particularly of its international reputation, and the global role it plays in setting standards and approving health treatments. It’s one of Britain’s great public sector assets, he believes, and its operation is crucial to our huge and important pharmaceutical industry. In the near future, though, Hudson is going to have to make some job cuts. He seems confident that he’ll be able to make them without enacting a redundancy programme. But nonetheless, like senior officials across government, he’ll need all of his diplomatic and leadership skills to sugar the sour pill of job cuts and civil service pay restrictions. And at that point, his gentle bedside manner will really come into its own.