Hansard

As all members have acknowledged, this has been a useful debate, but some questions remain unanswered.

Why should there be an inquiry? Why should we not just rely on the Earl Howe report on the MHRA, and on the two reports by Sir Bruce Keogh? Why are they not sufficient? As the minister said, those reports are helpful, but they are not sufficient, although they will and should inform our approach.

In her thoughtful contribution, Nanette Milne reminded us of the fraud by the manufacturer, but the issue is not one of blame. We are talking about ensuring patient safety. That is what regulation is about, and the regulatory system failed those patients, some of whom are in the gallery today.

The Earl Howe report says that the MHRA did all that it could, but it fails to examine whether the system of reporting was adequate, as reports were made directly to the company and might have been used as a substitute for an effective UK reporting system. Systems for reporting on adverse effects generally are an area of concern and, as Malcolm Chisholm said, there was a refusal to test at least some of the extracted implants.

The House of Commons committee has been justifiably critical of the Earl Howe report, although it is a pity that there has not been a greater analysis of it. The Government simply appears to have accepted it as being wholly valid.

I was somewhat disappointed in Maureen Watt’s contribution. Many of the women that we are talking about have had reconstructive surgery, but others who sought private implants did so for quite genuine and reasonable psychological reasons. Although I understand what she is talking about when she talks about the emphasis on body image, it is not particularly relevant.

The stories of the affected women are striking for a number of reasons. It is those women who are asking the Parliament to act to ensure that what happened does not happen again in either this or other contexts, and I will come to that point in a minute. It is those women who are asking for an inquiry in Scotland—because there is a Scottish dimension to the issue. It is they who want the situation not to arise here again.

A number of members have talked about the difficulties that the women encountered as the scandal unfolded. The French Government took strong and decisive action, which contrasted with the rather slower and more confused action that was taken at the UK level. Margaret Burgess’s description of the women’s distress resonated, and that was quite helpful.

When we are told that some women had to pay for removal of the device even once it was established that the producing company had switched from medical grade silicone to industrial grade silicone without telling us and had not passed on information about the level of ruptures, we have to question what private companies were doing.

Those affected tell us that there has been some suggestion of a postcode lottery, so I welcome the minister’s agreement to listen to and take up the issue for any woman who has not had a satisfactory response from the NHS. I hope that the campaign group will spread that information around so that some of the cases that we have already heard about can be raised.

When we hear about the woman who was not only charged for the removal procedure but was charged £100 for disposal of the removed device, we must question the ethics of the private company involved. Some women were also charged when the provider did not think that the removal of the device was necessary, but if a woman faced with the situation wishes to have the device removed because her anxiety levels have increased, she should be entitled to have it removed, especially given the level of fraud that has allegedly occurred. We have particular problems in Scotland, because class actions cannot be taken here, unlike in England, but that is a separate issue that I do not fully understand.

The Howe inquiry has gone so far and the Keogh inquiry will go further, so why do we want to establish our own public inquiry? It is not that we do not welcome both of those inquiries, but if we are serious about a potential move to independence, we will need to consider having not just a Scottish Medicines Consortium to authorise medicines, but a similar body—the 81st regional body—to authorise devices. With 27,000 devices approved, that would be no mean undertaking.

The EU may revise the rules on devices, but it is clear from the scandal and from the scandal that is going to unfold regarding metal-on-metal hip replacements that the regulation of medical devices—particularly those involving implantation—is inadequate. Moreover, we cannot look to the United States for better regulation, as they, too, have problems with what constitutes a threshold for notification by companies of changes in devices. They, too, have their own unfolding scandals.

Scotland and this Government have a duty of care to Scottish residents, as Jackie Baillie and Mary Fee made clear, which falls within the scope of an inquiry. What efforts did the Scottish Government make when the first medical alert came out in March 2010? We are not accusing the Government of inaction once the scandal began to evolve, but there was a medical alert in 2010. Did we, at that point, inform all the providers in Scotland whose regulation we have responsibility for that they must pay heed to that medical alert? Did we, at that point, talk to women who had had implants that were subject to the alert? No, we did not. There was delay, and that must be considered by the inquiry because the issue may also arise in relation to the metal-on-metal scandal that we will shortly face. We need much greater clarity and effort to ensure patients’ safety.

Some issues are reserved, and the MHRA deals with those. The Health Professions Council deals with the regulation of practitioners, but we have responsibility for determining the minimum standards of care, which can include things such as insurance cover and the medical qualifications that we believe are required. For example, should only dentists be able to perform tooth whitening? That is another issue that is coming up. There have been legal cases on the subject, but the fact remains that unqualified people are still performing tooth whitening. Eye laser surgery is not cosmetic, but the level of qualification required of those who undertake it in Scotland is not fully regulated beyond HPC level. Regulations in respect of companies that do marketing in Scotland or undertake surgery in Scotland should be introduced quickly. We passed legislation in 2010, we held a consultation in 2010 and the consultation was completed in July 2011, but we still have not had a report. We have not acted with speed on the issue of more effective regulation of high-street surgery and the private sector; it requires greater speed.

Those are all issues on which we believe a public inquiry is needed to ensure that Scottish patients are adequately protected going forward. I therefore support Jackie Baillie’s motion calling for a public inquiry.