My Lords, I say straight away that I sympathise with the intention behind the noble Lords’ amendments. These two amendments seek to make an explicit statement about the Health Research Authority’s role in encouraging transparency in health and social care research findings and clinical trial results.
We are all keenly aware of how topical the issue of transparency in health research is. The House of Commons Science and Technology Select Committee is currently undertaking an inquiry into clinical trials. Last week I gave evidence to that committee along with my right honourable friend the Minister of State for Universities and Science. I look forward with interest to the committee’s report. As the noble Lord, Lord Turnberg, and the noble Baroness, Lady Wheeler, rightly pointed out, maintaining trust in research is crucial to its success, and the way in which we respond to the mounting calls for greater transparency has consequences for how the integrity of research conducted in this country is perceived not just on a national level but on the international stage.
However, in reaching answers to these pressing questions, we must be careful not to create perverse incentives that simply result in people choosing not to carry out research in the UK and invest elsewhere. Promoting transparency in research is a core part of facilitating the conduct of safe, ethical research. People enrol in trials because they want to contribute to medical knowledge and advances. In considering the ethics of research proposals, ethics committees have to be assured that any anticipated risks, burdens or intrusions will be minimised for the people taking part in research
and will be justified by the expected benefits for participants, or for science and society. Knowing what research has already been undertaken or is under way and the results of that research is therefore essential in order to minimise risks and burdens by not repeating research that has already been conducted.
Here, I come to the answer to the question asked by the noble Lord, Lord Hunt, in debate on the previous group of amendments. Promoting transparency in research is inextricably part of facilitating the conduct of safe and ethical research, which is the Health Research Authority’s main objective in Clause 97(2)(b). As Dr Wisely, the Health Research Authority chief executive, said in evidence to the Joint Committee which scrutinised the draft Bill, promoting transparency is absolutely fundamental to protecting patients and the public in health research. As a special health authority, the Health Research Authority is already doing a number of things with regard to transparency in research. First, research ethics committees already consider an applicant’s proposals for the registration and publication of research, for dissemination of its findings, including to those who took part, and for making available any data or tissue collected as part of the research.
Secondly, since April 2013, the Health Research Authority has been undertaking checks of research ethics committee applicants’ end-of-study reports to see whether they registered and published research as they declared they would to the ethics committee. Thirdly, as noble Lords may be aware, the Health Research Authority recently published a position statement setting out its plans for promoting transparency in research. This statement has received widespread support from stakeholders, including the AllTrials campaign, the James Lind initiative, the Association of the British Pharmaceutical Industry and INVOLVE.
I turn specifically to Amendment 63, which would specify that one way in which the Health Research Authority, the bodies listed in Clause 98(1)—for example, the Human Tissue Authority—and the devolved Administrations would be able to fulfil their respective duties to co-operate would be through encouraging transparency in the reporting of clinical trials results. The intention behind these duties of co-operation is to encourage co-ordination and standardisation of practice so as to streamline regulation and remove duplication. The aim is that through these duties the people and bodies listed will work collaboratively with the Health Research Authority to create a unified approval process for research applications and to put in place consistent and proportionate standards for compliance and inspection. Streamlining the approval process for research will make initiating research faster for researchers, funders and sponsors, and ultimately enable people who use health and care services to benefit from research more quickly.
Noble Lords will be aware that clinical trials in this country are governed by EU law. The EU Commission’s current proposals for a new clinical trials regulation look likely to enshrine the principle of transparency in the rules governing clinical trials at every stage, including, as the current proposals set out, mandatory publication of clinical trials summaries, not only in their technical
form but in a form that ordinary members of the public will understand. We believe that that is the right direction of travel.
Given the focus of these duties on streamlining the regulatory system that the HRA has, I hope that noble Lords understand why it is not necessary to make encouraging transparency in reporting clinical trials a fundamental part of co-ordinating and standardising the regulatory practices of the persons and bodies listed and the devolved authorities. I hope that noble Lords are reassured by the fact that promoting transparency is a core part of the Health Research Authority’s main objective in facilitating safe and ethical research.
The noble Baroness, Lady Wheeler, asked about discussions with the national advisory council on health improvement drugs. Perhaps I may write to her on that topic. I hope she will forgive me for not answering now.
The noble Lord, Lord Campbell-Savours, asked about the patient information leaflet that is now mandatory within packs of medicines. The risks that are set out typically on the patient information leaflets can be derived in several ways: first, from the original clinical trials data—the noble Lord is quite right about that—but also from any data that may have subsequently arisen from the reporting system that exists. Pharmacovigilance legislation, which came into force last year, now enables the Medicines and Health products Regulatory Authority to require pharmaceutical manufacturers to report safety and efficacy data where either concerns arise or where the evidence for a medicine was perhaps less than it might have been in the first instance. So transparency can be promoted in that sense as well. The noble Lord may already be aware that the MHRA regards its pharmacovigilance responsibilities extremely seriously.