To ask Her Majesty’s Government what assessment they have made of the likely impact of proposed European Union legislation on their plans to sell confidential patient information to drug and insurance companies.
My Lords, I beg leave to ask the Question standing in my name on the Order Paper. In doing so, I refer noble Lords to my interests in the register.
My Lords, while we have concerns about the EU proposals, there has been no cause to conduct an assessment of the sort suggested at this stage. The Government do not sell confidential patient information to companies. Drug and insurance companies can receive patient confidential information only where they have a legal gateway, either consent of the patient or some form of statutory authority. In these circumstances the cost of providing information may be recovered, but it is not sold.
My Lords, clearly there is great advantage in using patient research in large-scale research projects. However, can the noble Earl assure the House that patient confidentiality can be assured? Also, is it right that projects such as the UK Biobank could be put in jeopardy were the proposed European legislation to be enacted in its current draft form?
My Lords, under the 2012 Act, the Health and Social Care Information Centre cannot release data that could be used to identify an individual without a legal basis to do so. As a result, there are strict controls about how such information is released. As regards the UK Biobank, the noble Lord is right to be concerned because the proposed text from the so-called LIBE committee would rule out the work of the UK Biobank, in that it would need explicit and time-limited consent for any research project that it undertook, instead of being able to support a range of research purposes, as it now can, using its existing consenting mechanism. So there is cause for concern if this text is adopted, but that is not yet clear.
My Lords, many noble Lords will have received recently a leaflet through their letter box, saying that their records are going to be made available unless they opt out. The means of opting out is to contact your GP. First, has anyone noticed how difficult it is to contact your GP in some circumstances? Secondly, would it have been beyond the wit of the department to include a simple, tick-box form for people to use? Does the absence of such a simple process lead us to conclude that the Government do not actually want people to opt out of making their records available?
My Lords, everybody in the country has a right to object to their data being shared. Those objections will always be respected. A practical way had to be found to enable that process to happen, and we believe that it is not unreasonable to expect a patient to have a conversation with their GP. I will, however, take the noble Baroness’s suggestions on board and feed them in.
Does my noble friend agree that while patients can object to having their records sent, they cannot, in fact, legally prevent the GP sending those records to the central repository? It is at that point that the discussion as to whether those records should be sold on and used by pharmaceutical companies and others is important. Does he agree that it is important that companies carrying out research into new drugs and compounds can access patient records, because they are an important dataset for making sure that we have better healthcare for our people?
My noble friend is correct. The UK has a unique advantage in being able to link patients’ data records for the purposes of research and for effective healthcare commissioning. It would be extremely concerning if European law prevented that. I believe and hope that patients will be encouraged that there will be no abuse of identifiable information. The controls around this are very strict and, in the main, only anonymised data are required for research purposes.
My Lords, there are circumstances in which potentially identifiable data can be released, but they are very severely circumscribed. A public health emergency is one, but Section 251 of the National Health Service Act 2006 could also allow identifiable information to be shared for specific purposes. However, the controls around that are extremely strict and the only people who can take that decision are the Secretary of State and the Health Research Authority—and then only after expert advice from the Confidentiality Advisory Group.
My Lords, some patients do not understand the implications and possible effects of the proposed EU legislation. What steps are being considered to ensure that those patients have full understanding?
My Lords, until we are clear about the text that is agreed at European level, it is difficult to issue public advice on what the effect of that proposed measure would be. The text is still being argued over. While my noble friend is absolutely right that a public information exercise would be advisable once we are aware, we are not at that point yet.