Clause 59 - Control of patient information
Health and Social Care Bill
9:30 am
Dr Liam Fox (Woodspring, Conservative)
Amendment No. 323 would ensure that any regulations made under the clause stemmed from a thorough process that involved all relevant bodies rather than from discussions between the Secretary of State and those who represent the interests of patients—as called for in Liberal Democrat amendment No. 286—or the whim of a Secretary of State, as could be construed from the present drafting.
The Bill restricts the availability of anonymised data, as the Secretary of State can prohibit or restrict the collection and use of data according to criteria determined by him. That is enforced by a £5,000 fine. The Bill can also require that patient identifiable data may be used without patient consent, if the Secretary of State deems it appropriate. The Government claim that they need those powers to prevent patient information from being used against the interests of patients, but they have not defined how such information could be used against the interests of patients, nor how those powers would affect the legitimate use of patient information—for instance, in drug trials.
The Secretary of State's powers to divulge data at his discretion do not appear in the national plan. They have been added without consultation as a way of restoring the attempted prohibition of the collection of anonymised data from retail pharmacists, which was rejected by the Court of Appeal in December 1999. The Government claim that the Bill closes a legal loophole, but the court did not find such a loophole. The judge said of the Department of Health's case that
``the law of confidence cannot be distorted''
for the Department's purpose. The Government may argue that clarity is required with regard to restrictions on the use of health data, but clause 59 does not provide that clarity.
Against what standards will the Government measure the public interest? The usual definitions are ``act of war'' or ``major infectious epidemic''. Are the Government aiming to expand that to include preventive medicine and medical research? The question remains whether the clause is designed to protect the NHS and Ministers or patients?
By restricting the control of data to prescribed commercial purposes, the Government overlook the fact that much of the research that charities and patient groups rely on for analysis originates from commercial bodies. Curtailing the availability of data to commercial bodies would curtail its availability to those monitoring groups that are not commercial.
Further clarification is needed. What consideration will be given to guidance issued by professional bodies when the Secretary of State uses his powers under the clause? How will he consult professional bodies and patient representative groups before using his powers? In what circumstances might it be necessary for confidential patient information to be shared without the knowledge or consent of the patient concerned?
In a letter to The Times, the president of the General Medical Council, Sir Donald Irvine, the chairman of the British Medical Association, Dr. Ian Bogle, the chairman of the Council of Heads of Medical Schools and Deans of UK Faculties of Medicine, Robert Boyd, the chairman of the Academy of Medical Royal Colleges, Denis Pereira Gray, and the chairman of the Joint Consultants Committee, James Johnson, stated:
``We agree with Alan Milburn . . . that we cannot accept the benefits of medicine, science or research regardless of the wishes of patients or their relatives.
However, Clause 59 of the Health and Social Care Bill threatens patient confidentiality by giving the Secretary of State for Health wide and ill-defined powers to determine what information should be disclosed in the public interest or for the improvement of patient care, without patients' consent.
We believe that any decision to override the citizen's right to privacy should be exceptional and must only be made—other than in an extreme medical emergency—after rigorous parliamentary scrutiny rather than by the order of a Secretary of State.
The Bill does not appear to provide for this.''
The letter that Committee members will have received from the Association of the British Pharmaceutical Industry raises the question of the appropriateness of the proposal. It states:
``In these days of deregulation and light-touch enforcement it seems inappropriate to deliver to the Government unfettered powers to suppress statistical information and prevent the use of anonymised data about patient treatment in the NHS, which should not be treated as the property of the NHS, and yet to give the Government very wide powers to obtain information confidential to patients.''
Indeed, the Government's approach contains a great contradiction. The Secretary of State said in a speech to patient groups in January 2000:
``The days have gone when the NHS could act as a secret society. It cannot operate behind closed doors. It cannot operate in the dark. It has to take patients into its confidence.''
Yet clause 59 will allow him to disclose identifiable information to third parties without patients' consent and despite their objections. The Government's approach is incoherent.
Other groups that have made representations--I imagine to both the Government and the Opposition--include the Royal College of Nursing, which is
``worried that the relationship of trust between themselves''—
that is, doctors—
``and their patients may be eroded by the Secretary of State's power to override their assurances of confidentiality.''
Behind the Government's action is the Source Informatics case, in which the Department of Health was found to have misinterpreted the law on the use of anonymised patient data. The Court of Appeal established that information about the treatment of patients was usable if anonymised, that pharmacists and doctors could supply it without breaching any obligation of confidence owed to patients, and that disclosure and use of information in that way was not unlawful. The Department had argued that pharmaceutical companies would use anonymised data to assist marketing efforts, which could affect the prescribing habits of GPs and therefore add to the NHS medicines bill. The Court of Appeal found that the Department of Health was wrong to seek to distort the law of confidence to achieve objectives relating to the medicines bill. It appears that clause 59 is an attempt to rectify matters, but the Government have undertaken no public analysis or discussion of the issues involved, and have not suggested what changes in the law they consider necessary or desirable. They have given no reasons for adding the clause to the Bill.
It could be argued that denying information to prescribers and manufacturers could increase the medicines bill by fostering inappropriate prescribing and delaying the introduction of new and more cost-effective drugs. Surely it is in the public interest that patients should be prescribed the appropriate medicine, and that the power to do that should not be arbitrarily curtailed by restrictions on the availability of accurate information. The court described the Government's arguments as not merely unconvincing but wholly unreal, and I am sure that that view will be echoed in Committee this morning.
The withdrawal of access to anonymised data will deprive pharmaceutical companies of access to such data. Research conducted by such companies is a key source of independent up-to-date information on drug usage. The clause will have a significant and damaging impact on monitoring the safety of medicines, and will hinder the ability of pharmaceutical companies engaged in medicines research. It will affect the fulfilment of regulatory obligations, including those that deal with adverse event monitoring and product withdrawals. Market shares of pharmaceutical companies will not be available. The success of this country's respected research and development sector will be compromised, and foreign pharmaceutical companies may gain an advantage.
One firm told us that commercial access to non-personal data provided considerable benefits to all concerned. The loss of that access will result in less efficient health care and less funding for medical research without any concomitant benefits to the Government, health care providers or patients.
The clause will also impede the collection of information by the likes of the national drugs safety research institute and the general practice research database. Such information is used to assess health care differences and inequalities, monitor drug safety and manage health care resources. The clause undermines all that good work. If the Government deny that that will happen, they must explain why they have introduced the clause and for what purpose they intend to use it. Even if the Government do not intend to use the powers in full, they must explain why they have given future Governments such massive scope to do so.
We believe that all those important changes in the law require the greatest scrutiny and the greatest consultation in advance. They are unacceptable increases in the power of Government, and could bring the medical profession into conflict with the law or the General Medical Council. They place unacceptable burdens on doctors and restrict information from many of those who would best use it in patients' interests, and in commercial interests.