Healthcare (International Arrangements) Bill

Debate between Lord Clement-Jones and Lord Patel

Report stage (Hansard): House of Lords
Tuesday 12th March 2019 Lords Chamber

[Lord Clement-Jones]

My Lords, the noble Lord used the expression, “giving force”. If those principles are given force, it means that the Government treat themselves and put on the record that they are bound by those principles. That is what giving force would mean in those circumstances, because these are novel circumstances set out in the Bill. That kind of reassurance is needed with the data ethics framework.

[Lord Patel (CB)]

My Lords, I had amendments that the Minister responded to at the Dispatch Box and I accepted her explanation at the time. Now I take the point that the noble Lord, Lord Clement-Jones, is trying to raise, that those principles that she enunciated about data protection included the Caldicott principles. As that reassurance was given at the Dispatch Box, I think it will cover the issue.

Data Protection Bill [HL]

Debate between Lord Clement-Jones and Lord Patel

Committee: 1st sitting (Hansard - continued): House of Lords
Monday 30th October 2017 Lords Chamber

[Lord Clement-Jones (LD)]

My Lords, that provokes me to add something. I am not entirely clear whether we are talking about something that is too narrow within the GDPR, or whether it is a lack of a suitably wide derogation on the part of the Government as part of the Bill. For all the reasons that the two noble Lords have mentioned, it seems extraordinary that the beneficial activities that they are discussing are not included as exemptions, whether explicitly or implicitly. It may be that the Minister can give us greater comfort on that, but I am not clear what is giving rise to the problems. As we heard in earlier groupings, I am a fan of having something more explicit, if anything, in the Bill, which is particular perhaps to medical research and other forms of research in that sort of area. But it is not clear whether that is going to be permissible under the GDPR or whether the Government can actually derogate from it in those circumstances.

[Lord Patel]

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.

Health and Social Care Bill

Debate between Lord Clement-Jones and Lord Patel

Monday 28th November 2011 Lords Chamber

[Lord Clement-Jones]

My Lords, I shall speak to Amendments 127B and 197B. As they relate to pharmacy, I declare an interest as the chairman of the Council of the School of Pharmacy, University of London. The intention of these amendments is to ensure that all relevant healthcare providers, including community pharmacists, are consulted when the NHS Commissioning Board and commissioning groups are discharging their functions and developing their business and communications plans. The essence of these amendments is to retain the long-standing arrangement whereby, under the 2006 Act, commissioning bodies have to consult widely and in good time with all relevant stakeholders, including local service providers or their representatives.

Under the current system, primary care trusts are required to consult widely in relation to their commissioning duties. There is concern in the pharmacy profession that the current provisions under Clause 20, new Section 13J, for the board, and Clause 23, new Section 14V, for clinical commissioning groups, to obtain appropriate advice are too vague. It is important that consultation with all local healthcare providers should be done via local representative bodies as well as directly with providers. Clinical commissioning groups should consult pharmacy professionals when making decisions in relation to the commissioning of relevant services in order that the professional skills, knowledge and expertise of pharmacists are used in planning, commissioning, delivering and evaluating NHS services. They should also demonstrate arrangements systematically to seek the views of all appropriate local clinical groups throughout the commissioning process, in general and for particular services. This would include ensuring that all local representative committees are fully engaged in the commissioning process and signed up to the outcomes agreed.

As part of their local leadership role, clinical commissioning groups also need open and transparent processes for reconciling different professional perspectives and contingency arrangements for seeking the agreement of non-GP professional groups in the case of urgent service change. These processes should be clearly set out as part of the CCG’s governance procedures for commissioning decision-making. The above will be of particular importance in the immediate term, given the influx of new commissioners into the market, to ensure commissioners commission services effectively. Without relevant healthcare providers being consulted, the different contributions that such providers, including pharmacy, can make to local healthcare could be lost.

If used effectively, pharmacy has the potential to deliver a great deal more both to patients and commissioners. For example, it is estimated that some 57 million GP consultations each year involve minor ailments which could be dealt with at a pharmacy. If these patients could be moved to a pharmacy, more than £812 million could be saved annually, and GP capacity could be freed up to deal with more complex cases.

In summary, it is critical that there is a duty on commissioning groups, when developing their commissioning plans, to consult primary care providers such as pharmacists as there is a danger under the proposed legislation that some groups may not do so, leading to ineffective commissioning of services. At the Royal Pharmaceutical Society Conference in September, the Minister said that pharmacists are pivotal to every aspect of the Government’s plans to modernise the NHS. I find those words very encouraging and hope that he can give further encouragement in the course of this debate.

[Lord Patel]

My Lords, I support the amendment of the noble Lord, Lord Warner, on patients holding their own records. Speaking from personal experience, I know that it was not uncommon in maternity services years and years ago for patients to be given their old, shared maternity card. The difference was that that card was extra to the actual notes, so what doctors and midwives wrote in those cards was probably an abbreviation.

For 25 years of my life, I allowed patients to carry their complete set of records, thus avoiding having to write another card. That meant that what you wrote and what you told the patient had to be precise, and clear thought had to be given to the purpose of writing it down. It also taught people not to use abbreviations that do not mean anything, or that might be misconstrued. It is not uncommon for doctors to use abbreviations such as SOB or NAD. They do not mean what you think they might mean. SOB stands for “Shortness of breath”, and NAD stands for “No abnormality discovered”. This also meant that when you were putting the results of diagnostic tests into the notes you were forced to explain to the patient what those results meant. If the results were ambiguous, then you had to explain to the patient what that ambiguity was. That improved the quality of record keeping, communication with the patient and the quality of care given to the patient. In 25 years of allowing thousands of my patients to carry their own notes—and some of the noble Lords sitting today are well aware of my habits—I lost only two notes. One was eaten by a dog in the patient’s house and the other was torn up after being left by the mother-to-be on a bus. Apart from that, there was no loss of notes, while in hospitals usually you can hardly find any notes.

There is a double issue here. How do we make notes that are compatible—easy to write and yet which communicate with the patient. An electronic version is better, but even a hand-written version works. I am convinced that allowing patients to carry notes is not a problem.