Policy responses and statements
- Name of organisation:
- Medicines and Healthcare Products Regulatory Agency (MHRA)
- Name of policy document:
- MLX 339: Challenges and Priorities for the MHRA
- Deadline for response:
- 2 November 2007
Background: This consultation sought views from stakeholders on how the MHRA should respond to the key challenges and priorities in the coming years. Also circulated was the publication “Medicines and Medical Devices Regulation - What you Need to Know” which includes a full explanation of what the MHRA does and how it does it. As the Agency develops its strategy for its second five years, it needs to gather the ideas and perceptions of the widest possible range of stakeholders.
The MHRA is the organisation responsible for overseeing medicines and medical devices in the UK, to ensure that they work and that they are acceptably safe. The specific areas of focus in the consultation document are:
Strengthening the MHRA's ability to safeguard public health, in particular through more effective arrangements for monitoring safety of products on the market as part of a lifecycle approach to regulation;
Building further on the MHRA's information and communication functions, ensuring that its regulatory task is better understood, and that professionals and the public have the information they need on benefits and risks to support their healthcare choices;
Linked with this, developing better ways of involving the public in benefit-risk decisions, and reflecting their views and preferences;
The MHRA's contribution to science, research and innovation, ensuring that the regulatory framework supports rather than hinders the exploitation of new technology for the benefit of healthcare;
The MHRA's increasingly important focus on cooperating with European and other international regulators, as the most effective way to serve UK public interest;
The MHRA's fitness as an organisation to respond to change, ensuring that it maintains and grows its expert capability, working efficiently and flexibly, and target its resources to risk in line with Better Regulation principles.
COMMENTS ON
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)
MLX 339 - CHALLENGES AND PRIORITIES FOR THE MHRA
The Royal College of Physicians of Edinburgh is pleased to respond to the MHRA on MLX 339: Challenges and Priorities for the MHRA.
We believe it is timely for the MHRA to reflect upon policies and direction of travel over the next five years. We welcome the various objectives set out in this document, but would offer the following general comments in addition to comments upon the specific questions posed for response.
We feel that the MHRA must continue to keep in mind its central objectives, namely the assessment and subsequent licensing of medicines and medical devices after rigorous risk benefit analysis. Hand in hand with this function is the obligation to monitor the use of the approved products in order speedily to detect and warn of hazards. This is no easy task in a rapidly changing and advancing pharmaceutical environment, particularly with the development of new genetic and biological products. These are the central roles which clinicians expect of the organisation.
Whilst the public demands ever newer treatments it also remains concerned about potential side effects, particularly when the industry and, more recently, the regulator has been branded as villain. Recent high profile problems have meant that the MHRA has been taken to task, notably by Commons Select Committees. As a result, the MHRA has changed its structure and, we feel, has perhaps become more inward looking. We feel that the agency has lost its recognisable public faith by changing the name of its key committee, the Committee on Safety of Medicines, to the Commission on Human Medicines, certainly in the eyes of the medical profession. The public face of the agency is obviously important for its perception both to doctors and the public at large.
The other key aspect which has changed is the MHRA’s relationship to its formal regional monitoring centres (now called Yellow Card Centres). The Metters report seems to have downgraded the ability of the YCCs to function independently of MHRA in pursuing adverse drug reactions, and we feel that this has led to some loss of goodwill from medical professions in the longstanding regional centres. The importance of regional monitoring centres should be acknowledged and valued by the MHRA in order to maintain goodwill. The introduction of YCCs across the whole United Kingdom would be welcome and we feel should assist the MHRA’s profile.
We also feel that there is a need for the MHRA to provide greater support to both undergraduates and postgraduate efforts to provide education about medicines and pharmaco-vigilance.
Our responses to the specific questions posed in the document are as follows:
1. Are there areas within its responsibilities where the Agency could do more to contribute to public health?
There are three areas in which we feel the MHRA should be more active.
Firstly, the new role in respect of herbal medication must be vigorously pursued since it is completely illogical that unlicensed, untested and potentially toxic herbs are available from a variety of unlicensed practitioners. These compounded pose a significant public health risk.
Second, there is a need for the MHRA to mount a major campaign on the safe use of the internet as a means of accessing information and of procuring medicinal products. This area is rapidly expanding, virtually unregulated and again we feel poses serious public health implications.
Thirdly, as alluded to above, the visibility of the MHRA and understanding of its functions amongst health professionals is, we feel, now quite low. Recent changes in the acronyms used by different expert committees is not well understood and MHRA should consider publishing an explanation of its new structure in a high profile journal, such as the BMJ, which might also include a résumé of the changes in medical licensing within the European framework.
2. How can the Agency encourage you to report problems you experience (as a professional or as a patient) with medicines and medical devices?
As physicians we need easy methods to report ADRs. The document acknowledges the huge potential for records linking studies from computerised GP records with which we agree. Such a system for a hospital physician is not yet in place, and we feel it is therefore necessary to increase the culture of safety within the NHS such that the reporting of ADRs is more clearly a professional duty; a new nationwide YCC network would facilitate this.
3. What are your views on whether the Agency strikes the right balance on benefits, risks and informed choice in the actions it takes to safeguard health?
We acknowledge that the MHRA is in an invidious position. If it withdraws a drug too soon it is accused of preventing good treatment being available to patients, whereas, if it delays until more information is available, it is accused of prevarication and causing unnecessary suffering. The view of our contributors was that the MHRA strikes this balance well and performs well in this function, but is perhaps less good at communicating this success to the general public and the profession.
4. How should we best communicate the benefit-risk balance associated with medicines and medical devices?
The same difficulties apply. We do not have any easy answers.
5. What information sources do you trust on the benefits and risks of medicines and medical devices, and why?
We feel that this will very much depend upon the individual and their particular interest. Probably most physicians will rely upon the BNF and reputable medical journals. The MHRA’s policy on ADRs and drug safety issues is a good initiative which needs to be more aggressively advertised to the profession.
6. Are there other ways in which we can develop our role in the provision of authoritative information?
Again, we advocate development of the website. This could include public information about the risk benefit of medicines including a realistic appraisal of the uncertainties surrounding safety in the early stages of the marketing process of new products.
7. What practical approaches could the Agency take to involve patients and the public – and reflect their views – in regulatory decision-making?
We feel that this is largely a politically driven initiative of unproven and dubious value. There is always a danger of special interest groups being duly influenced by the working of such public bodies.
8. Are there other areas in which we could improve our transparency and openness?
The Agency has a problem, particularly in respect of material that is classified as “commercial in confidence”, which means that public discussion of many of the issues discussed in committee is not possible. Whilst some information can be disseminated, the confidentiality issue can mean that published minutes are of very limited value.
9. What are your views on the technological advances to which the Agency will need to respond in the coming years?
The main technical advances in terms of medicines licensing relate primarily to genetic developments and biological products, particularly new cytokines. Product development in this area is a challenge for the pharmaceutical industry but also a challenge for the MHRA since the requirements for the assessment of the products will continually change with developing science. Likewise, the introduction of new materials, such as drug eluting implants, can also provide difficulties, particularly since large animal studies could well be impossible and therefore careful monitoring of new introductions into human medicine will require even more detailed scrutiny.
10. What are your views on how the balance is currently struck between supporting research and innovation, and taking a precautionary approach to prevent harm?
& 11. Do you have a view on the proposal to move to earlier, conditional licensing of medicines?
We feel that the Scottish health system could play a vital role in this area. Scotland has a much better data link system than England and Wales with major potential and ability to review safety data at an early stage after drug license. The challenge is the issue of patient confidentiality, such that the ideal should be that patients who are receiving treatment should be persuaded that the data should be used for the public good. This would require legislation.
In addition, there are challenges and significant risk associated with conditional licensing. The terms of the conditional licence would need to be clearly laid out, together with the grounds for moving to removal of the drug or its unconditional licensing. In addition, there would need to be mechanisms in place to ensure that work required to secure a full licence was proceeding at a suitable pace. Furthermore, if the drug did not perform on efficacy grounds there might be difficulties with removing it from the market that would not exist under the current scheme.
12. What are your views on how the Agency should balance its national and European activities?
Licensing decisions in Europe are increasingly impacting on the UK and it is likely that separate national agency may not be required in due course. However, we feel it is important to maintain the individual skills within the MHRA for use in Europe, particularly since other national agencies have a less vigorous scientific approach to our own. For this reason, we do not believe that mutual recognition should be adopted at present.
13. Do you have views on the future development of the EU framework for medicines and/or medical devices regulation? Are there changes or improvements you would want the UK to support?
A single system that used the best expertise from all countries, without the necessary requirement for representation from all countries would be best.
14. Where should the MHRA target its international cooperation work (either in terms of countries, or areas of work)?
The UK is seen as an excellent place to obtain a license by companies and there is scope for collaboration in the developing world rather than Europe.
15. Do you have any comments on the organisational issues set out in this section?
No comment.
16. Do you have proposals for further Better Regulation improvements in the regulation of medicines and medical devices?
No comment.
Copies of this response are available from:
Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.
Tel: 0131 225 7324 ext 608
Fax: 0131 220 3939
[2 November 2007] |
