Chamber
Meeting of the Parliament 14 June 2012
14 Jun 2012 · S4 · Meeting of the Parliament
Item of business
PIP Silicone Breast Implants
Thank you, Ms Baillie. I confess that I was not at the Health and Sport Committee meeting that day—I was in hospital getting my gallbladder removed. However, on reading the evidence it looked as though the figure of 1,300 women was perhaps more robust.
How, under a regulatory regime that crosses Europe and the UK, could we come to the position that we have been in for the past year? There are three European directives that cover medical devices. Those directives have been implemented into UK legislation by the Medical Devices Regulations 2002. They are there to regulate safety and performance and to include provision for mandatory CE markings. Under that EU framework, we have REACH—the registration, evaluation, authorisation and restriction of chemicals. Under that architecture, we have the European Chemicals Agency, which is responsible for the CE marking. Parallel to that, we have the competent authorities in each member state; in the UK, the competent authority is hosted by the Health and Safety Executive. Under the competent authority are the notified bodies, which are appointed and accredited by the member states. In the UK, the notified body is the UK Accreditation Service—UKAS—whose role is to ensure that the design and manufacture of products make them safe and compliant.
Given that extensive regulatory framework, how was the fraud possible? I turn to the Howe report, which has already been quoted. Earl Howe said that the review found that the MHRA fulfilled its obligations regarding incidents that involved the implants, and that the MHRA’s work was hindered by a lack of complete or reliable evidence. Much of the information came from a manufacturer that has been found to have been working fraudulently.
Given all that, Howe concludes that there is nothing to suggest that the system for regulating medical devices is unsound and that the responsibility lies squarely with the fraudulent manufacturer. I must ask a further question: is the regulatory regime flawed? When I look to see what the REACH regulation was founded on, I find that it states that it
“places greater responsibility on industry to manage the risks from chemicals and to provide safety information on the substances.”
How, under a regulatory regime that crosses Europe and the UK, could we come to the position that we have been in for the past year? There are three European directives that cover medical devices. Those directives have been implemented into UK legislation by the Medical Devices Regulations 2002. They are there to regulate safety and performance and to include provision for mandatory CE markings. Under that EU framework, we have REACH—the registration, evaluation, authorisation and restriction of chemicals. Under that architecture, we have the European Chemicals Agency, which is responsible for the CE marking. Parallel to that, we have the competent authorities in each member state; in the UK, the competent authority is hosted by the Health and Safety Executive. Under the competent authority are the notified bodies, which are appointed and accredited by the member states. In the UK, the notified body is the UK Accreditation Service—UKAS—whose role is to ensure that the design and manufacture of products make them safe and compliant.
Given that extensive regulatory framework, how was the fraud possible? I turn to the Howe report, which has already been quoted. Earl Howe said that the review found that the MHRA fulfilled its obligations regarding incidents that involved the implants, and that the MHRA’s work was hindered by a lack of complete or reliable evidence. Much of the information came from a manufacturer that has been found to have been working fraudulently.
Given all that, Howe concludes that there is nothing to suggest that the system for regulating medical devices is unsound and that the responsibility lies squarely with the fraudulent manufacturer. I must ask a further question: is the regulatory regime flawed? When I look to see what the REACH regulation was founded on, I find that it states that it
“places greater responsibility on industry to manage the risks from chemicals and to provide safety information on the substances.”
In the same item of business
The Deputy Presiding Officer (John Scott)
Con
The next item of business is a debate on motion S4M-03294, in the name of Jackie Baillie, on women’s health.10:27
Jackie Baillie (Dumbarton) (Lab)
Lab
I welcome the opportunity to debate the PIP breast implant scandal.I welcome some of the women who have been caught up in the scandal, who are here today cam...
The Minister for Public Health (Michael Matheson)
SNP
I welcome the opportunity to have the debate. I also welcome those from the Scottish campaign group who have joined us for the debate. They have been at the ...
Dr Richard Simpson (Mid Scotland and Fife) (Lab)
Lab
One of our concerns is that the second Bruce Keogh review—not the toxicology review—is on cosmetic procedures only. There are many other procedures, such as ...
Michael Matheson
SNP
The review is dealing specifically with the issues that arise from the PIP implant matter, and we should give the review group the opportunity to consider th...
Nanette Milne (North East Scotland) (Con)
Con
I thank Jackie Baillie for bringing forward the debate, because although we do not agree with her conclusions on the issue we think that it is important that...
Jackie Baillie
Lab
In recognising the scale of the problem, does the member support a public inquiry being held at UK level?
Nanette Milne
Con
I will give the member my reasons for not doing so later.We must remember that silicone implants carry an inherent risk to an individual’s health. No such im...
Fiona McLeod (Strathkelvin and Bearsden) (SNP)
SNP
We are in a serious and worrying situation, so I am glad that we are having this debate. We should take the opportunity to reassure the many women out there ...
Jackie Baillie
Lab
I was quoting the cabinet secretary, who has consistently said that we would perhaps be safer using the upper limit, which is 4,000 women.
Fiona McLeod
SNP
Thank you, Ms Baillie. I confess that I was not at the Health and Sport Committee meeting that day—I was in hospital getting my gallbladder removed. However,...
The Deputy Presiding Officer (Elaine Smith)
Lab
Come to a conclusion, please.
Fiona McLeod
SNP
I contend that the EU and the UK have swung too far towards self-regulation and self-policing. Given that Scotland has no voice in Europe and only a small vo...
Mary Fee (West Scotland) (Lab)
Lab
When I first heard about the PIP silicone scandal, I was shocked. I still cannot comprehend the feelings of anguish and worry that must have been—and still a...
Margaret Burgess (Cunninghame South) (SNP)
SNP
I can only imagine the stress and anxiety that are felt by women who have PIP breast implants. For some time, they have lived with that worry day and daily. ...
Dennis Robertson (Aberdeenshire West) (SNP)
SNP
I, too, welcome members of the campaign to the chamber. However, although I have a great deal of sympathy for their situation, I am not sure that a public in...
Jackie Baillie
Lab
I did not invent the 4,000 figure; it actually came from the member’s own Cabinet Secretary for Health, Wellbeing and Cities Strategy. Nevertheless, the poin...
Dennis Robertson
SNP
As I said, the 4,000 figure came from the UK Government and relates to the purchase of implants. The cabinet secretary was quite right to highlight the upper...
Malcolm Chisholm (Edinburgh Northern and Leith) (Lab)
Lab
I first became very concerned about the issue a few weeks ago when a constituent came to one of my surgeries and showed me photographs of two breast implants...
Maureen Watt (Aberdeen South and North Kincardine) (SNP)
SNP
There has been much debate about exactly how many women in Scotland, the UK and across Europe might be affected. Those numbers remain unclear, but we can be ...
The Deputy Presiding Officer
Lab
We turn to the closing speeches. I call Nanette Milne. You have up to five minutes.11:17
Nanette Milne
Con
This has been a worthwhile, interesting and considered debate with good speeches from members in all parts of the chamber. As I said previously, it is import...
Jackie Baillie
Lab
This is not about apportioning blame, but about learning lessons of responsibility for the after-care of the women so that the same mistakes do not happen in...
Nanette Milne
Con
I appreciate that, but I still think that the on-going work and its conclusions will satisfy.It is certainly true that we can continue to improve regulation ...
The Deputy Presiding Officer
Lab
I call Michael Matheson. I can give you around seven minutes, minister.11:22
Michael Matheson
SNP
Thank you, Presiding Officer.It has been a useful debate. I think that, on reflection, most members would recognise that this is an issue that goes beyond pa...
Jackie Baillie
Lab
Will the minister take an intervention?
Michael Matheson
SNP
I am very short of time and I want to cover as many points as I can.A number of members mentioned the introduction of a register. Some members may be aware t...
Dr Richard Simpson (Mid Scotland and Fife) (Lab)
Lab
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 ...