Editorial

Headlines concerning health at the end of 2011 and beginning of 2012 were dominated (apart from the ongoing disquiet about the Health and Social Care Bill) by the PIP breast implant scandal. The issue has stirred up a hornet's nest, with everyone from the Secretary of State for Health down being drawn into the debates that followed. I believe the incident speaks volumes about the system of health regulation in the UK and attitudes to regulation per se, as well as casting a much needed spotlight on the murky world of the cosmetic treatments industry.

It was somewhat surprising as well as disappointing that the whole affair appeared to catch the Department of Health unprepared. The problems with the implants had been known about for a considerable amount of time. The French inquiry had been ongoing for about a year before they announced that they would replace the implants free of charge for any woman who had had them. One would have thought that the powers that be would have seen that this was going to be a big issue and that there would be serious and difficult questions to answer. In the event, women who will have been in an extreme state of anxiety were given confusing and sometimes contradictory information and advice. The issues which the Department of Health had to grapple with were complex, but they had had plenty of time in which they could have thought about them without making up policy on the hoof.

What was fascinating was how the Secretary of State could do no more than appeal to the conscience of the private cosmetic surgery industry to pay for the replacement of the questionable implants. He said it was their ‘moral responsibility’ to do so. NHS patients who wanted them replaced would have this done by the NHS. Private patients whose private provider refused to replace them could have the implants removed on the NHS but not replaced. The stance that the NHS takes care of its patients and the private sector should take care of its patients is hard to argue with, provided that any patient needing urgent treatment is not denied access to NHS services. However, what was skimmed over in the discussions around all of this was that the State owed some responsibility for the whole problem because of the inadequate system of regulation it had in place, which had allowed the scandal to happen in the first place and which placed no requirement either on the manufacturer of the faulty product or the provider carrying out the surgery to put things right at their own expense or to provide redress. The Medicines and Healthcare Products Regulatory Authority (MHRA) could and should have acted earlier. It had known of problems with previous PIP implants. It reportedly ignored the pleas of women and their solicitors and refused to meet with them. The Care Quality Commission, with whom all the providers are required to be licensed, and whose registration requirements are set in statute by the Department of Health, does not require the provider to have adequate insurance/indemnity arrangements. Difficult then for the Secretary of State to speak with authority over the providers' responsibilities, and rather naïve to rely on the moral compass of private profit-motivated companies who prey on the vulnerabilities of people seeking a cosmetic improvement to their appearance.

Some good will hopefully come from the mess. The Department of Health has announced that it will conduct a review of the regulation of the cosmetic healthcare industry. This is welcome but it does smack of déjà vu. In 2005 a Department of Health convened group made a series of recommendations for tightening up the regulation of this industry. Some of those recommendations have simply been mothballed. In some respects the opposite direction of travel has been taken to that which the working group was advocating. In 2010 the previous government actually removed the use of certain types of laser equipment used for cosmetic treatment (such as hair removal, moles, etc.) from statutory regulation altogether. This was done in spite of medical experts and bodies such as AvMA telling them that to do so would lead to patients being harmed at the hands of untrained and unregulated people in unsuitable premises. The Government's own impact assessment conceded that that would be the case, and indeed it is. It still concluded that that was a reasonable price to pay for freeing up the industry from ‘red tape and bureaucracy’ (e.g. regulation). Subsequently, again in spite of the objections of medical experts, responsible representatives of the industry itself, and representatives of patients, the Government has refused to regulate cosmetic treatments such as Botox and dermal fillers at all. We currently have to rely on a makeshift voluntary register run by and for the industry. It is better than nothing, but a poor second best. These are disasters waiting to happen. It is not just AvMA who say so but even the Independent Healthcare Advisory Service itself.

Treatments which have the capacity to cause serious harm should come under the regulatory powers of the Care Quality Commission. Any organization requesting a license to provide such treatment should have to demonstrate that it protects patients' interests by having in place appropriate insurance/indemnity to guarantee patients' remedial treatment and compensation where appropriate. When it comes to healthcare products like the implants, we were pleased to see an idea AvMA had floated aired by the Department – an ABTA-type insurance scheme to protect patients' interests in the event of faulty products and/or producers who go out of business. The MHRA itself should be reviewed and potentially overhauled. It is too close to and over-reliant on the industry whose products it regulates. It has fallen down on its job too many times. It is not long ago that it allowed the drug Avandia to cause harm. Finally, there is a need to resist the ideological labelling of regulation as something inherently undesirable. Patient safety should be put before politics.