The National Pharmacy Association (NPA) has in membership virtually all community pharmacy owners throughout the UK. We welcome the opportunity to comment on some of the issues raised in the MHRA’s Consultation Document.

CHAPTER 2

Question 2 and Paragraphs 2.4 to 2.19

Pharmacists are already encouraged by the NPA and others to report suspected adverse reactions to medicines, under the “Yellow Card” scheme and we have not received any reports of any difficulties in doing so. We do not believe that further encouragement by the MHRA is needed.

We support the extension of the reporting regime to include direct reporting by patients (Paragraph 2.4). However, we consider that in any MHRA publicity designed to encourage such reporting, patients should be recommended also to provide the information to the pharmacy from which the medicine was obtained. In the case of generics, only those in the pharmacy concerned will know the generic supplied. We assume that there are sufficient safeguards in the regime to avoid “double recording”.

In Paragraph 2.7 it is mentioned that the GPRD is expanding its coverage to take advantage of the possibilities that will arise from the development of fully electronic patient records throughout the National Health Service. As is made clear in the document “Medicines and Medical Devices Regulation – What you need to know”, the GPRD contains anonymised records of patients registered at some 450 GP practices. If and when the database is expanded to electronic patient records throughout the NHS, patients will need to be reassured, bearing in mind the wide use of the database, that all the information collected will continue to be anonymised and the “opt-out” provision must be maintained.

The increasing challenge of counterfeit products reaching the “legitimate wholesale and pharmacy supply chain” is raised in Paragraph 2.14. Community pharmacists welcome the commitment of the MHRA to make the UK a “hostile environment” for counterfeits and will, of course, co-operate fully with the Agency in this regard. However, when community pharmacies order supplies of medicines via their usual wholesalers, they would expect to have confidence that effective safeguards are in place to prevent counterfeits reaching that supply chain. It seems to the NPA that the main focus of the Agency should be to secure identification of counterfeits at the wholesaler level if patients are to be adequately protected. Pharmacy stock control methods mean that normally only small quantities of a medicine are ordered to replace stock dispensed and the new stock may be used within a few days, making effective recall from pharmacy level uncertain.

Paragraphs 2.15 to 2.18 deal with the role of the Agency within the broader public health field. Paragraph 2.16 raises the role of the MHRA in “supporting policies on wider access to treatment and self-care.” Pharmacies are at the heart of safe and responsible self-care. In our letter covering this submission, we have requested a meeting. We want to ensure that the staff of the Agency are fully aware of the control measures that are in place in every pharmacy, including the requirements for the training of all members of staff whose role includes responding to requests for medicines or advice on treatment of common ailments. We wish also to be sure that all members of the CHM are aware of these safeguards since we had concerns on this point in the recent discussions on medicines containing pseudoephedrine. We would go so far as to say that it should be a requirement that anyone who is a member of the CHM undergoes training in the basic principles of pharmacy law and ethics and practical aspects of community pharmacy practice

The NPA strongly supports reclassification from prescription-only to pharmacy medicine wherever the available evidence supports such a switch. Patient safety is always the main criterion, taking into full account the controls on the supply of pharmacy medicines in pharmacy premises. The criterion of safety should also be the sole criterion when reclassification from pharmacy medicine to general sale list is under consideration. That is the thrust of the relevant legislation and any other factors raised should, in the view of the NPA, be irrelevant as far as the MHRA is concerned.

We also consider that it is desirable for the Agency to use the term “non-prescription” instead of “over the counter” medicines in describing medicines that are not prescription-only. The use of the term “over the counter” seems to the NPA to encourage people to regard these medicines as ordinary articles of commerce, which they are not.

CHAPTER 3

Paragraphs 3.1 to 3.10

The strategic priorities of the Agency’s Communication Strategy are set out in Paragraph 3.4. The NPA wholeheartedly agrees with the comments in earlier paragraphs in this Chapter on the key role in decision making of good quality and reliable information.

The NPA considers that the Agency has an important role to play in informing people on how best to use the internet to obtain information and particularly the caution that should be exercised in using the internet to order medicines. It would be especially worthwhile if the Agency focused its communications aimed at the public, towards advising people on how best to identify websites which can be relied upon.

The Agency also has a responsibility to provide timely information directly to the public whenever an issue on safety in relation to a medicine comes to light.

However as far as information about medicines generally, or a specific medicine, is concerned, we consider that the role of the Agency should primarily be to encourage people to seek advice from the healthcare professionals with whom they have contact. The research carried out by Ipsos MORI for the Agency demonstrated clearly the trust that those who participated had in health professionals, to provide accurate information about the risks and benefits of medicines. This research should inform the Agency on the best approach to adopt in its communication strategy aimed at the public, on how best they can obtain advice on medicines or medical treatments.

We welcome the assurance in Paragraph 3.6 that the MHRA will continue to oppose any move to allow direct to consumer advertising (DTCA) of prescription-only medicines. To the best of our knowledge, DTCA for these products is permitted only in the USA and New Zealand. The government of New Zealand has indicated publicly that it would wish to reverse this situation but at present does not have the necessary majority in the one-house Parliament. It is probable that the regulatory authorities in the USA would also welcome a ban on DTCA for prescription-only medicines. The EU should not let this genie out of the bottle.

It is also mentioned in Paragraph 3.6 that the Agency “will support efforts at EU level” to improve the information available on medicines. The NPA also supports that aim and is making a positive contribution to discussions within DG SANCO, through the Pharmaceutical Group of the EU of which we are members.

We have concerns, however, over the thrust of the recent document from DG Enterprise which appeared to promote the concept that pharmaceutical manufacturers should be permitted to provide “information” to the public about medicines, in addition to that which they are currently able to give (summary of product characteristics, patient information leaflet and any correspondence initiated by individual patients about their medicinal products). Some years ago, the Pharmaceutical Committee of the EU made the point that distinguishing between “information” and disguised promotion was extremely difficult.

The difficulty of preventing “disguised promotion of a product” was well illustrated in the case of the insert aimed at pharmacists, sponsored by AstraZenica and distributed via the Pharmaceutical Journal. There were no breaches of advertising regulations because the insert was directed at health professionals but there were no fewer that six breaches of the PMCPA code. Two of these were “failing to ensure claims were accurate, balanced, fair, unambiguous and based on up-to-date evidence” and “Making claims that could not be substantiated.” And it became apparent that action could be taken, under the voluntary code, only after the insert could be said to have achieved its promotional objective.

The NPA would therefore be opposed to any extension of the type of information that pharmaceutical manufacturers are permitted to provide directly to the public about prescription-only medicines. Having said that, the NPA recognises the importance of pharmaceutical companies as sources of detailed and up-to-date information about their products and welcomes initiatives to utilise the input of such information to an independent source to be adapted for provision to patients in a professionally moderated form.

The NPA also welcomes partnerships between the industry and all other stakeholders (healthcare professionals, government, patients, academics etc)  to develop and present to the public high quality, accurate, unbiased, and comprehensive information about medicines.  The medicines information project is one such initiative.

CHAPTER 4

Questions 9 and 11 and Paragraphs 4.1 to 4.5

The issue of developments towards “personalised” medicines is raised in Paragraph 4.3. And Question 9 relates to the technological advances to which the Agency will need to respond in the coming years. It is for others to forecast likely scientific advances. But one related issue on which attention will have to focus is on the distribution arrangements for so-called “personalised” medicines. Significant expansion of direct to patient distribution has potential mid to long term adverse impact on the efficiency of the current supply chain on which the great majority of people will continue to depend for convenient access to both prescription and non-prescription medicines.

One proposal in the Cooksey review on the earlier “conditional” licensing of medicines, subject to appropriately robust levels of safety monitoring is highlighted in Paragraph 4.4 and Question 11 seeks views on this suggestion.

If “conditionally licensed” medicines are to be available for prescribing by general practitioners, or in any arrangement leading to their being supplied from pharmacies, we consider it would be essential to incorporate community pharmacies in the increased level of monitoring of safety and, indeed, efficacy in use. This would provide a vital safety net for patients and ensure that both the MHRA and the marketing authorisation holder received vital feedback about the product so that the “conditional license” could confidently be changed to a full marketing authorisation. Such a role would clearly have cost implications for pharmacies but presumably there would be costs benefits for manufacturers, and patient benefits in getting innovative products to market earlier albeit within a more controlled environment. The NPA would welcome the opportunity, in cooperation with the MHRA to explore the process and develop a business case for community pharmacy based monitoring of “conditionally licensed” medicines.

CHAPTER 5

Questions 13 and 14. Paragraphs 5.4 to5.8

Through its involvement at EU level and contacts with the EMEA, the NPA recognises the leading role that the MHRA has played, and is continuing to play, in influencing the development of regulation of medicines throughout the EU, to the benefit of patients and the public generally. We consider it important that this activity should continue and that the MHRA should reinforce its role as a leading contributor to the work of the EMEA. The scope of the portfolio of the EMEA will undoubtedly expand in the future and it is important that the MHRA should retain a strong voice as the EU itself expands and regulatory standards for medicines in applicant countries are subject to scrutiny.

To that end, the NPA fully agrees with the statement in Paragraph 5.4 that the interests of the UK will best be served by the MHRA retaining expertise across all types of medicines and enhancing capacity in new areas of regulatory work. We believe that any other approach would have potential for weakening the influence of the organisation and damaging the morale of staff so making recruitment and retention of the best qualified more difficult.

In Paragraph 5.6, the question is raised as to whether there should be a body at EU level akin to the EMEA, to deal with the regulation of medical devices. The NPA considers that the establishment of such a body would have advantages and would assist the MHRA in achieving the objectives set out in this Paragraph.

Our response to Question 13 is therefore that the NPA would welcome the establishment of a body at EU level that, in the field of medical devices, would play a role similar to that undertaken by the EMEA for medicines.

So far as the future development of the EU framework for the regulation of medicines is concerned, the EMEA has published its “road map” and has valuable consultation processes in place for both the health professions and patients and consumers. The NPA would expect to have an input at national level through the MHRA and at EU level via our membership of the Pharmaceutical Group of the EU, to any discussions on proposed changes to the medicines regulation framework.

CHAPTER 6

Paragraphs 6.1 to 6.11