Medicines and Medical Devices Safety Review — House of Commons, 2018-02-21
Topic: Health
Jonathan Michael Graham Ashworth (Labour, Centre-left): I thank the Secretary of State for the advance copy of his statement. I welcome the tone of his remarks and generally welcome his commitment to a review of medical device safety, although I note that the 2017 Labour manifesto called for an inquiry into medical devices and product licensing and regulation. Today’s announcement is an acknowledgement that there are major problems, going back decades, to do with safety and lack of proper scrutiny and research. In debate and Committee, Members in all parts of the House have offered moving testimonies about the devastating impact of mesh, Primodos and sodium valproate on the lives of thousands of women and children in our constituencies. I wish to put on the record my thanks and tribute to all the campaigners and the MPs from across the House, but especially those who have worked so hard with the all-party groups, including my hon. Friends the Members for Pontypridd (Owen Smith) and for Bolton South East (Yasmin Qureshi), and the right hon. Member for North Norfolk (Norman Lamb), who have all spent many years campaigning for justice on these issues We have heard how mesh implants have left women in permanent pain, unable to walk, unable to work. This is an ongoing public health scandal, and we hope the Government will do much more to support those who are affected. Mesh has been suspended in Scotland and banned in other countries around the world. I understand that mesh has been paused for use in cases of prolapse. Will the Secretary of State consider fully suspending mesh use while the review is carried out On Primodos, the Secretary of State indicated that the Department will drive forward and "accelerate" the recommendations of the expert working group, but does he accept that that report was met with concern on both sides of the House? Indeed, campaigners branded it a whitewash I am grateful to the Secretary of State for including sodium valproate. My constituent, Emma Friedmann, took sodium valproate during and after her pregnancy, leaving her son, Andrew, with severe autism along with hearing and sight problems. Andrew, who is now 18, needs round-the-clock, full-time care. Emma, like thousands of others affected, was never fully informed of the risks of taking sodium valproate during pregnancy. Last year, a charity survey found that almost one fifth of women who are taking the drug still do not know the risks that the medicine can pose during pregnancy. I welcome the Government’s efforts to raise awareness of the dangers of sodium valproate, but will the Secretary of State tell us whether the review will look at the guidelines for clinicians who prescribe it to women of childbearing age We offer the review our support, but note that it falls short of the calls for a full public inquiry, which campaigners have been demanding. Will the Secretary of State give the House an absolute reassurance that the review will gain access to medicine regulation files held in the National Archives, access to any valuable evidence cited in unsuccessful legal actions and access to documents and information held by pharmaceutical companies and that all such material will be made public Does the Secretary of State agree that those affected must have trust and confidence in the review? Who will the noble baroness report to, and who will provide the secretariat to the review? I say this with no discourtesy to the Department or the Medicines and Healthcare Products Regulatory Agency, but does he agree that the review must be independent to avoid any sense of conflict of interest that has hampered previous inquiries? I understand the steer that he has given to the noble baroness on setting the terms of reference, but I press him to ensure that victims agree with the terms of reference to maintain trust and confidence in the review. Is the Secretary of State now ruling out a full public inquiry, or is he saying to victims that they should wait for the review’s outcome? When can we expect it to report back to the House? More broadly, can he reassure us that the inquiry will have three separate strands that will look in depth at each issue to ensure that nothing gets watered down and lost In the broader context of Brexit, when profound uncertainty remains about medical and device regulation as we leave the European Medicines Agency, does the Secretary of State agree that the review must inform future regulatory mechanisms and take into account how we best co-operate with other national and international regulators post Brexit? What assurances can he offer the House that the medicines and devices that women use today—especially pregnant women—will not become the tragic and desperate scandals of the future On the treatment of the victims involved, the Secretary of State will know that many women have been denied access to legal aid to pursue compensation claims. Does he agree that women and children deserve full compensation and support? Is that not the Government’s responsibility? Will they establish a compensation fund, and what consideration has he given to compelling the pharmaceutical industry to support a compensation fund for those affected Finally, mesh, sodium valproate and Primodos have devastated the lives of hundreds of thousands of women and children. Is it not time that they were given a full apology? Surely, that is the very least they deserve.