RESPONSE FROM THE ROYAL COLLEGE OF ANAESTHETISTS TO THE MHRA TRIENNIAL REVIEW
There is no need to answer all the questions unless you wish to do so. For those which you do answer, please provide evidence to support your answers wherever possible. If you wish to send us supporting documentation please provide this as an attachment. Information where relevance is not demonstrable will not be accepted as evidence. The review team is unable to respond to individual cases or consider complaints. Any such issues should be directed to the MHRA. Individually identifiable information should be avoided.
Performance, capacity and capability
- How would you rate the performance of the Agency?
o Average
Our clinical respondents have reported some negative experiences in dealing with the agency, specifically that the agency is slow in responding to raised concerns and slow to issue guidance. Some have reported that they have felt that the Agency can have an obstructive, rather than helpful attitude when approached by clinicians on research issues.
- Where do you think the Agency performs particularly well or needs to improve?
Our respondents would like the Agency to be more responsive and act quicker when issues arise.
With the increasing computerisation of equipment it also needs to ensure that it is capable of responding to issues around networking, security and hacking of biomedical equipment.
Our clinical respondents are satisfied with the information they receive from the Agency on medicines and medical devices, however it would be very helpful if the BNF and MHRA could work together to ensure that they issue matching guidance.
- How well does the Agency respond to relevant public health issues, e.g. safety issues with products, product defects, or new priority concerns?
Our respondents felt that the Agency’s response is good, but can be slow and there is a feeling that it will struggle to cope with increased computerisation and use of robotics in medicine.
- How effectively does the Agency balance risk/benefit decisions?
Generally well, although some bad decisions have been made, for example on the use of hydroxyethyl starch (HES) drips.
- How well does the Agency negotiate and influence nationally and internationally? How might it exploit further opportunities?
Some respondents felt that the Agency does not do enough to control medicines labelling especially with Generics (manufactured overseas). Many of the problems with “wrong drug” incidents is down to poor labelling and similar font/design of the labels from one drug to the next when from the same generic manufacturer. While is it is true that the end user bears a responsibility, with the increasing pressure to increase throughput through theatres and hospitals, this is an accident waiting to happen and it will be the doctor or nurse that dispenses the drug that is going to be in trouble, not the manufacturer. Guidance to hospital pharmacies on informing large use departments of a change in supplier would also be helpful.
- How well does the Agency support innovation and what more could be done?
N/A
7. How well does the Agency communicate and engage with its stakeholders?
o Good
Generally good - our respondents understand the difficulties of disseminating information to the right people in large organisations and at the moment the speed of the information cascading down to the end users is dependent on individuals within Trusts and hospitals. Perhaps a more effective and reliable way would be to use intranet facilities within the NHS, such as targeted mailshots to relevant departments.
- How would you measure the performance of the Agency?
N/A
9. How effectively do the various elements of the Agency work together? Are there more synergies that could be achieved? Further information is provided in Annex I of the response form.
N/A
Functions
10. Is there a continuing need for the functions undertaken by the Agency?
o Yes
Our respondents agree that the functions undertaken by the Agency are vital for the safe use of medicines and medical devices.
11. Are there any functions that should be added, dropped, undertaken by another organisation, or which overlap with another organisation?
Safety reporting is an area which could require a better joined up effort amongst different organisations dealing with incident reporting.
12. How effectively does the Agency contribute to wider government policy? Are the Agency’s activities effectively aligned with the rest of the health and social care system?
Our respondents feel that more weight needs to be given to the decisions from the Agency, especially now that more and more trusts are “Foundations”; in many cases bigger teeth may be needed to ensure compliance by management , even if there is a financial penalty.
Form
13. The section ‘About the MHRA’ explains some of the recent changes and mergers. Annex II (in the response form) below provides brief background on potential options for different forms and structures. Do you think the Agency should:
oRemain in its current form (Executive Agency and Trading Fund)
14.If the Agency continues in its current form, are there opportunities for greater cooperation and joint working with other organisations?
o Yes
Our respondents suggest closer working of the Agency with organisations that have oversight on critical incident reporting (such as the Medical Royal Colleges) and which often have huge amounts of data that would be of use. If all this information was shared across various agencies the amount of useable data would be increased and analysis improved.
Efficiency
15. How could the Agency reduce costs or improve performance through efficiencies?
N/A
16. Are there any opportunities for the Agency to make more effective use of its assets and/or to increase commercial revenues?
N/A
17. The Agency applies a licence fee to fund its medicines’ regulatory activities. Do you think devices’ regulation should operate under a similar funding model?
o Yes
Possibly, but there is concern that the granting of licence fees for devices will be driven by marketing and profit, rather than effectiveness of designs.
However, if correctly applied, a licence model would put tighter control on equipment, reducing the number of devices on the market (there is currently a plethora of prostheses on the market), whilst allowing only properly assessed devices to be available. An added bonus of the licence model would be to put a curb on the rise in counterfeit products.
Governance
18. Does the Agency follow best practice governance arrangements?
N/A
AC GAT - From what I know, yes I believe so.
19. How effective are the Agency board and senior management team?
N/A
20. How well are risks and opportunities identified and managed?
N/A
Other Comments
21. Are there any other issues or evidence you think the review team should take into account?
N/A
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