Data Protection Bill [HL] — House of Lords, 2017-10-30
Topic: Health
Narendra Babubhai Patel (Crossbench, Unknown): I shall respond to some of the points raised. First, on the research ethics committee, we established through legislation—and I remember the debates that we had—a national Research Ethics Committee to deal with all applications for biomedical research, but particularly research involving patient data and transfer of data. If I as a clinician want to do a trial, I have to apply to that committee with a full protocol as to what consent procedures and actual research there will be, and what will be the closing time of that consent. If I subsequently found the information that I had could lead to further research, or that the research that I had carried out had suddenly thrown up a next phase of research, I would have to go back to the committee and it would have to say, "Yes, that’s part of the original consent, which is satisfactory to progress with the further research". It is a robust, nationally driven, independently chaired national ethics committee, apart from the local ethics committee that each trust will run. So the national ethics committee is the guardian Furthermore, there is a separate ethics committee for the 500,000 genomes project, run by the Wellcome Trust and other researchers; it is specifically for that project, for the consent issues that it obtains, the information given at the time when the subject gives the consent and how the data can be used in future. The genomes project aims to sequence all the 500,000 genomes, and to link that genome sequence data with the lifestyles that people had and diseases that they developed to identify the genes that we can subsequently use for future diagnosis and treatment—and to develop diagnostic tests that will provide early diagnosis of cancers, for instance. The future is in the diagnostic tests. Eventually we will find them for diseases which have not developed but which have a likelihood of developing. Those diagnostic tests will identify the early expression of a protein from a gene and then find a treatment to suppress that expression well before the diseases develop, rather than waiting until the cancer develops and then treating it. All this is based on the data originally collected. At this stage, it is impossible to know where that research will lead—that is the history—apart from the clinical trials which are much more specific and you get consent for them. I realise that there is a limit to how much the text of the Bill can deviate from the GDPR, unless it is dealing with specific issues which the GDPR permits member states to provide derogations for. I realise that, post exit, the UK will need an adequacy agreement and some equivalent, neutral recognition of data protection regimes between the UK and the EU. We need that for the transfer of data. For instance, the noble Baroness, Lady Neville-Jones, has talked about extremely rare diseases, which require the exchange of data across many countries because their incidence is low and no one country could possibly have enough information on that group of patients The research exemption does not undermine agreement on Clause 7—which is what the noble Lord, Lord Clement-Jones, was leading up to when he asked about the ethics committee. The noble Baroness, Lady Neville-Rolfe, suggested that medical research should be possible through the research exemption, but that has to be wide enough yet not specific enough to encompass wider exemptions. I hope that the Minister will come up with that trick in an amendment which he might bring forward. It will not be restrictive, yet protect the patient’s personal interest There is a research exemption for processing specific categories of data, including health data. The legal basis for this is through article 9 of the GDPR, referred to in Part 1 of Schedule 1 to the Bill. However, all processing of personal data also needs an article 6 legal basis: research is not exempt from needing this. I am arguing today that research needs that exemption, defined in wide enough terms. For processing special categories, you need both an article 6 and an article 9 legal basis. We need to have provision for both in the Bill. One of the article 6 legal bases is consent and I have explained why this is not suitable for much research. The other feasible route for universities and other public bodies processing personal data for research is public interest. This is why it is so important to be clear on what processes can use this legal basis There was serious concern about the likely impact of the GDPR on research as it was being drafted. However, this was successfully resolved and it provides the necessary flexibility for the UK to create a data protection regime that is supportive of research in the public interest. The Government, and other UK organisations, worked hard to make sure that this was the case. The provision is there: it is now for the Government to act on it. It is also important to seek an adequacy agreement post Brexit: we will have to have one. It will be vital to consider the need to retain, post Brexit, cross-border transfers of data for research. I give the same example of rare diseases as the noble Baroness, Lady Neville-Jones, used. The Government have recognised the value of retaining a data protection regime consistent with the EU, but the research community would welcome knowing whether it will seek a status of adequacy as a third country or an equivalent agreement The plea I make is that unless we include a provision, and there are exemptions which can be written in the Bill in the format that is required, we will not be able to carry out much of the research. A question was asked about the life sciences industrial strategy. It is the key pillar of the Government’s industrial strategy Green Paper. It relies on data that the NHS collects and the data that the science community collects and marrying up the two to produce, and lead the world in, treatments and developing technologies. If we are not able to do this, the whole thing will be unworkable.