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Earl Howe: I thank all noble Lords who have taken part in this very interesting debate, not least those such as the noble Lord, Lord Walton, my noble friend Lady Cumberlege and the noble Lord, Lord Winston, who have supported me, but also others such as the noble Lord, Lord Turnberg, and the noble Baroness, Lady Gibson, who have disagreed with me and done so in a very gracious and measured way.
I still believe that the provisions on anonymised data are misconceived. The point is that without anonymised data it is impossible for pharmaceutical companies to find out who is using what drugs. The better the information, the stronger the downward pressure on prices because of the pressures of the competition. That is the way in which the market works. The industry can help the NHS manage patients better. In the process all kinds of essential information emerges, such as adverse reactions and so on. Therefore, the onus is on the Government to produce evidence to justify subsections (1) and (2). So far, they have not done so.
On the issue of identifiable patient data, the starting point should be that it is wrong for any Secretary of State to take powers to allow access to named patient records by third parties without the patient's knowledge or consent. I welcome very much what the Minister had to say about the primacy of that informed consent. The whole thrust of the clause is in the opposite direction. I look particularly at subsection (4) which would oblige doctors to disclose information even when they and the patient do not wish to.
Any exceptions to that general principle should be allowed only for reasons of overriding public interest. Each exception should be considered individually on a case by case basis with full parliamentary deliberation.
I took particular note of the comments made by my noble friend Lady Cumberlege on the disclosure of confidential data. The consequences when that goes wrong can be devastating, but also, as she alluded to, the erosion of trust that it causes eats away at the general fabric of the relationship between doctor and patient and the way that the public view the medical profession. It will eventually be very damaging to research.
The crucial issue which remains obscure is the force of subsection (8). That is the subsection which says that nothing in the clause can be inconsistent with Clause 29 of the Data Protection Act. I still do not understand to what extent and under what circumstances the requirement for informed consent can be overridden by those powers. My advice is that the informed consent requirement is overridden by the word "expedient". The Minister should turn his attention to that matter between now and Report stage.
The noble Lord, Lord Turnberg, spoke of retrospective studies; studies that looked back to data perhaps involving deceased patients and so on. It would be perfectly possible to phrase a power to cater specifically for cases which look back into the past. However, the point is that the power as expressed in the Bill is objectionable because it can override informed consent going forward. The principle which should guide us here is that consent should be obtained in order to be ethical.
I noted that the Minister felt that this is a transitional power and a temporary arrangement. If that is what he believes it should be, perhaps he would agree to a fully fledged sunset clause instead of the permanent ongoing duty for review as in subsection 6(a).
I worry about the potential for conflict with international commitments. A Council of Europe Recommendation No. R975 on the protection of medical data, to which the UK is a signatory, appears to be at odds with this clause, as does the declaration of Helsinki on ethical principles for medical research involving human subjects. I have read sections which appear to be unequivocal.
I very much regret that the Minister does not see fit to put any extra safeguards on to the face of the Bill. I was hoping that he would agree to that, because I think that it would meet the objections of many people--but not those of everyone--as regards the disclosure of identifiable patient data. The assurance that has been given in another place and here in Committee on the creation of an advisory committee is welcome as far as it goes, but I feel that this is something that should go on to the face of the Bill if we are to sleep easier in our beds.
I do not believe that it would be appropriate to call a Division at this hour and I shall not do so. If we do reach Report stage of the Bill, then the amendment or the excision of this clause, will be a prime focus for many noble Lords. In the meantime, I beg leave to withdraw the amendment.
The noble Earl said: In moving the amendment, I speak also to Amendments Nos. 303, 306 and 314. These four amendments arise from concerns expressed to me by the Royal Pharmaceutical Society of Great Britain. In brief, they all seek to achieve one thing; namely, to ensure much greater consultation with the relevant professional bodies before the various statutory instruments that will emanate from Clause
The first two amendments clarify that the existing subsection (9), which ensures consultation before tabling secondary legislation, is applicable to both sets of secondary legislation that will be introduced. The third amendment then seeks to strengthen subsection (9) by incorporating a form of words used in the Health Act 1999 to ensure greater scrutiny by providing a three-month period of time for consultation. Such a period would provide the right balance between proper consultation and the effective implementation of legislation.
The fourth amendment addresses issues of access to and use of anonymised patient data, clarifying the areas where the use of anonymised data can and, indeed, should continue. It also provides a requirement for the Secretary of State to be satisfied that patient data can continue to be used for research, that consultation has taken place, and that such consultation has been reported on. A great deal of information of potential use in public health strategies is captured on community pharmacy patient medication records. The development of medication management as part of NHS modernisation plans will require new approaches to sharing appropriate patient records so that the best possible outcomes can be arrived at within the therapeutic partnership.
It is important for the Government to ensure that the correct balance is struck between protection of patients, concern for record-keeping and data management and the ability of NHS contractors, such as small pharmacists, to control their own business processes. I shall be interested to hear the Minister's comments on these matters. I beg to move.
Amendment No. 306 requires the Secretary of State to publish draft regulations in advance of consultation, to consult representatives of the professions concerned by the regulations and to lay the regulations before Parliament, amended as necessary three months later.
The intention of the amendment appears to be to establish a three-month deadline for consultation while ensuring that the professions most directly affected are consulted. It would have the effect of removing the wider requirement to consult that is set out in the clause by a narrow requirement that looks only to the professions. As drafted, it also requires regulations to be laid before Parliament, perhaps modified to take account of views expressed regardless of the outcome of consultation. It also attempts to impose a deadline of three months on a process that should be considered and thorough, particularly where confidential patient information is concerned, where there may be a need to question and probe any proposed regulations.
We wish to ensure that all those who may be affected by regulations have an opportunity to voice any concerns, not just important but narrowly defined groups. We are particularly concerned, for example, to hear the concerns of industry organisations in relation to any proposed regulations under subsection (1) and patient organisations in relation to regulations under subsection (3). Although the aim of the amendment may have been to bring a degree of certainty to the consultative process, it does so in a way that could conflict with the consultative and thorough approach we have developed around this clause.
The intention of Amendment No. 314 appears to be to ensure that the use of anonymised information for medical research is not prevented by any regulations made under this clause. Let me say from the outset that that is an objective that I share. But I do not believe that the amendment is the right way to achieve it.
There are two regulation-making powers in the clause: subsection (1) and subsection (3). The government amendment to subsection (1) has been accepted and it will be possible to use the power only in relation to NHS patient information for marketing and other promotional activity which the Secretary of State considers to be contrary to the economic interests of the NHS. In consequence, the power to make regulations under that subsection will be limited in such a way that regulations could not be made that would prevent the use of anonymised information for medical research.