Passing the buck


The clinics which fitted faulty PIP implants have a "moral and social duty of care" to provide aftercare to their clients. So says professor Bruce Keogh, medical director of the NHS (pictured), giving evidence to the House of Commons Health Select Committee last week.

He then acknowledges that the government has no powers or mechanisms to enforce that "duty" on private sector providers. Chairman Stephen Dorrell asked whether there was any opportunity for legal redress, and got an extremely equivocal response from Keogh.

Compare and contrast this with the stance taken by professor Laurence Kirwan, Harley Street plastic surgeon and Fellow of the Royal College of Surgeons.

Kirwan has taken exception to guidelines Keogh sent to GPs, NHS Medical Directors and plastic surgeons last month. Under the heading "Criteria for replacement of implants at NHS expense" the Department of Health's letter refers to private patients offering to pay for replacements from the NHS because they have been "failed by their providers".

"We have received a number of queries from patients with PIP implants supplied by private providers where the provider has failed in its duty of care", says the letter which was signed by the Chief Medical Officer, professor Sally C Davies.

But, says prof Kirwan, "I will not endorse the statement that the private provider has 'failed in his duty of care' because he has placed a perfectly legal implant approved by MHRA in a completely ethical and legal setting as did the NHS". He adds: "The fault lies with the regulatory agency and they should take full responsibility for removal as well as replacement".

Interestingly, not once throughout the Health Committee proceedings did europhile Stephen Dorrell mention that the CE marking system was part of the fabled Single Market, or in any sense suggest that the regulatory authorities bore any responsibility, even though it was admitted that there had been a "regulatory failure". He steered the committee very firmly to focus on the responsibilities of the clinics which had provided implants.

Back, in Brussels health and consumer policy commissioner John Dalli then had the nerve to call on member states "for immediate action to be taken at national level to ensure full and stringent implementation of the current legislation on medical devices".

However, in a de facto admission that the current system was defective, he said that the priority was "for the Member States and the Commission to act together to tighten controls, provide a better guarantee of the safety of medical devices and to restore patient confidence in the law that protects them".

Dalli has thus outlined his proposals for a joint plan of immediate measures in a letter written to the health ministers of EU member states, asking for their full co-operation in beginning work without delay.

This is on the basis of an earlier report from the commission, asking for "further scientific study" and drawing "first lessons from the recent fraud on breast implants".

Against that background, Keogh on the one hand is determined to contain the impact of this scandal on the resources of the NHS, while Dorrell seems most concerned that the clinics should live up to their "obligations".

Thus do they seek to pass the buck, so who is there to point the finger at the EU and its responsibility for a failed system, and at the French government for its failure earlier to detect the fraud?

And what about these europhiles who are so keen on the Single Market, which includes a single market in medical devices? Where is the "moral and social duty of care" of these people, who so easily seek to dump the responsibility on clincs who relied on the authority of the CE marking?

The attitude of Dorrell seems to me to sum up the europhile tendency – everybody is responsible for their actions, except themselves. They immediately stand aside when there is any chance of blame coming their way. When there is a "regulatory failure", the private providers have a "moral and social duty of care", which requires them to remedy it. If that is not passing the buck, I don't know what is.


Richard North 11/02/2012 link

The beat goes on


Today's agenda, the politico-media establishment has decided, is the Court of Human Rights in Strasbourg, hence The Boy toddling off to that French city to make an inconsequential and carefully guarded speech on the subject, about which we are supposed to throb with excitement.

Somewhere, the idea of "sovereignty" will get mentioned – if not by The Boy, then certainly by some hacks, but even as they expostulate, that very thing drains away from the entity loosely described as the British nation.

No one, however, can ever complain that is passage was not recorded, but in the most obscure and secret form, in such a manner that it almost certainly never sees the light of day – the "Written Ministerial Statement".

Two such of interest were promulgated yesterday, the first one from the Minister of State, Foreign and Commonwealth Office (Mr Jeremy Browne): and The Parliamentary Under-Secretary of State for Transport (Mike Penning).

This was "to update the House on the Government's response to the sinking of the Costa Concordia cruise liner, which hit rocks off the Italian island of Giglio overnight on Friday 13 January" – not that it will do so as so few MPs will read it – but the key passage is below, which the point of greatest interest emphasised:
At this time, the cause of the accident remains unknown. We must wait for the results of the investigation by the Italian authorities before deciding whether any action is required to ensure the safety of other vessels. Should the conclusions of the investigation suggest a need for revisions on any aspect of cruise ship design or operation, then the International Maritime Organisation (IMO) will be the forum for agreeing improvements. The development of passenger ship regulations is an iterative process based on practical experience. By applying the lessons from previous incidents the cruise industry generally enjoys an excellent safety record.
Compare and contrast this with what The Boy was saying, now exactly a week ago during PMQs, viz: "if changes need to be made … of course we will make them".

What he actually meant to say, as we now see, is that the British parochial council will go toddling along to the Albert Embankment in London, where the IMO houses its secretariat, to get its instructions.

In due course, i.e., after interminable meetings, the 170 member states (and the EU, which will also be represented) will come to a conclusion (sort of). This then will be adopted by the EU, either in the form of a regulation or (more likely) a directive, which our parochial council will turn into British law.

So much for making changes, which neatly brings us to the second statement of interest, this one on: "PIP Breast Implants and Regulation of Cosmetic Interventions". Here, we are reminded by the secretary of state for health (Mr Andrew Lansley) of his oral statement to the House of 11 January 2012.

Then, he described the immediate action which the Government were taking to address the concerns of women who have received breast implants made by the company Poly Implant Prothèse (PIP), saying that:
… in the light of these events, we needed both to review the lessons that could be learnt, and to consider the wider issues of ensuring the safety of people who are considering cosmetic surgery and similar treatments. I therefore announced two reviews, one to be led by my noble Friend the Parliamentary Under Secretary of State (Earl Howe) which will look at what happened in the United Kingdom in relation to PIP implants; and the second, to be led by the NHS Medical Director, Sir Bruce Keogh, to look at the wider issues of clinical safety and regulation.

One will notice immediately, the complete absence of nay mention of the "elephant in the room" but now, in the written statement that so few will see, it comes out to graze. The review to be carried out by Earl Howe, we are now told, will report by the end of March 2012 and the terms of reference are set out thus:
In the context of current EC directives on the regulation of medical devices and the information generally available at the time on the risks associated with breast implants to review …
Then we find that the review will advise the secretary of state "on what lessons can be learned for application should similar circumstances arise in the future, and on implications for UK input to the ongoing review of the European Medical Devices Directives".

As regards the review to be carried out by Sir Bruce Keogh, this will take into account "the Government's Better Regulation framework and the concurrent review by the EU of current arrangements for the regulation of medical devices".

The purpose, as one might expect, is to "make recommendations to Ministers, including interim recommendations if appropriate, and to inform the UK contribution to the EU review".

That, as "revealed" by written ministerial statements, is how modern government works. On the one hand, a foreign shipping disaster is to be referred to an international committee and, eventually, the EU will reach down and make more laws, which we will adopt without question.

On the other hand, with a domestic medical "disaster", the great and the good are summoned to carry out reviews, the effect of which is "to inform the UK contribution to the EU review". When it has finished its own review, the EU will then reach down and make more laws, which we will adopt without question.

Interestingly, had we by now left the EU, we would still be talking to the IMO, but would be adopting its recommendations directly, instead of via the EU. As regards the breast implants, were we to have joined EFTA and via that the EEA, we would still be waiting for an EU review and adopting any regulations that came from it. Nothing much would have changed.

The key thing, though, seems to be that, as long as the politico-media establishment doesn't actually know (or care) how modern government works, it can go on pretending that The Boy and his ministers are still in charge and, until we give away the Falklands, that the sun never sets on the British Empire.


Richard North 25/01/2012 link

A failure of regulation


In an interesting twist to the ongoing "breast implants" drama, the BBC reports that the Harley Medical Group, which fitted more PIP breast implants than any other UK cosmetic surgery firm, says it will not replace them free of charge. It claims that replacing the banned implants would put the company out of business.

On the other hand, the government says private clinics which fitted implants have a "moral duty" to remove them, a stance which is disputed by Mel Braham, chairman of the Harley Medical Group.

He says the government must accept "moral responsibility" for replacing the PIP implants. "We're only sitting here today because the Medicines and Healthcare products Regulatory Agency (MHRA), their own regulatory authority, has approved these implants and obviously hasn't done their proper checking".

He adds: "We're an innocent victim like everyone else, we're attempting to do our best for our patients", then asserting: "We can't take on this whole thing on our own, especially when it wasn't our fault".

Braham is not on his own. Nigel Robertson, the head of the cosmetic surgery firm Transform, says: "Private sector providers with large volumes of patients do not have the resources to ensure the removal and reaugmentation of all PIP implants free of charge".

He then declares that the government plans are "unworkable" and again blamed "a catastrophic failure of the regulation" by the MHRA.

And these two men are right to pin the blame on a regulatory failure. But the failure goes much further than the MHRA. It strikes at the very heart of the regulatory system which is wholly a creature of the European Union.

At the front end, however, the MHRA describes itself as "the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe" and tells us that it keeps watch over medicines and devices, and takes " any necessary action to protect the public promptly if there is a problem".

The MHRA itself exercises control through detailed legislation, which currently includes four sets of Medical Device Regulations. These, though, simply implement EU Medical Devices Directives and amendments, specifically the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. This has been amended many times with a consolidated version also available, the latest amendments coming into force in the UK in March 2010.

The central part of the legislation - part of the Single Market corpus - is a system of prohibition from marketing unless the product (or "device") conforms with detailed technical standards, with assured manufacturing and quality control measures in place, subject to ongoing inspections and approval by the regulatory authorities. If all conditions are met, the device is awarded a CE mark, which acts as a marketing authorisation.

As regards breast implants, these are covered by the Directive, the applicable standard being EN ISO 14607:2009 which refers to "Non-active surgical implants - Mammary implants". The particular requirements are set out in ISO 14607:2007.

The trouble is that these particular implants were manufactured in France and therefore came under the control of the French authorities. They actually shut the firm down last year, but not before 40,000 British women had been fitted with the implants.

Herein lies the problem. The British agency, ostensibly responsible for maintaining standards in the UK, is also obliged under EU law to permit the import and marketing of any device which bears a CE mark, even though it has no direct jurisdiction over the manufacturer.

Furthermore, unless it has direct evidence to suggest that there might be something wrong, the MHRA is not even allowed to carry out its own tests to ensure that imported products bearing the CE mark conform with the required standards.

Thus, the actual failure rests with the French authorities, who approved a substandard product, and allowed as many as 300,000 to be sold. But the ultimate failure rests with EU legislation which has created a system which is beyond the control of the British authorities, and enables substandard products to be marketed in the UK, with no domestic checks.

Bizarrely though, health secretary Andrew Lansley cannot admit to what amounts to the failure of the Single Market, so beloved of Tory politicians and the Dear Leader. "Every provider has a responsibility to put things right," he says, without mentioning the EU. He then adds: It is not fair for the taxpayer to foot the bill and that if the NHS was forced to remove an implant "the government would pursue private clinics to seek recovery of our costs".

Certainly, it would be unfair for the taxpayer to foot the bill, but Lansley needs to focus on where the blame really lies – first in Paris with the French government, and then in Brussels, which has foisted us with a dangerous and unworkable system.

Lansley has announced a review of how the situation emerged in the UK: "The blame for what happened lies with PIP, but this review will enable us to learn lessons to improve future regulatory effectiveness," he says. But he has no powers in this matter, and nor can his remit extend to looking at the French failures.

The competence rests with the French government and the EU commission, and his only remedy is to go cap in hand to Brussels to beg for improvements, the current code being: "We will be working closely with other health departments and regulators in Europe to consider whether there are wider implications for the regulation of implants and other medical devices".

The worst of it is that there are no regulatory changes that can be made that will improve the situation. Back in July 2004, we made the point that drug companies (and by inference, device manufacturers and surgical users), as a rule, actually favour tight regulation. The "market authorisation" (and CE marking) effectively insulates producers from claims by users who have been harmed by their products – as anyone who has tried to sue a drug company will readily attest.

And so it is today. Without legislative intervention, Common Law "duty of care" provisions would apply and every affected woman would be entitled to a remedy from her supplier (the fitting clinic).

But all we get from this complex web of EU law is an egregious failure which blurs responsibility and makes it more difficult for those affected to gain a speedy resolution - enabling the likes of the Harley Medical Group (rightly) to duck the blame.

Yet this is another of those wonderful benefits of our membership of the EU – and another reason why we should leave.


Richard North 12/01/2012 link

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