Policy responses and statements

Name of organisation:

Medicines and Healthcare Products Regulatory Agency (MHRA)

Name of policy document:

Concept paper on the project to consolidate and review medicines legislation

Deadline for response:

27 March 2009

Note: Purpose:

The purpose of this concept paper is to seek the input of stakeholders into the project on the review and consolidation of medicines legislation. The last 40 years has seen a growing number of amendments or expansions of the legislation which governs medicines for human use in the UK. Given the changes that have taken place over the years there is a strong case for reviewing and consolidating current legislation.

The document identifies a number of areas where possible reforms can be made. The MHRA invited views from stakeholders on the areas that are outlined, and other areas which they feel warrant attention.

Background: The vast number of amendments and expansions of medicines legislation over the last 40 years has resulted in a very complex and fragmented set of legal provisions. The MHRA has recently commenced a project with one of the goals being to seek opportunities to make improvements and to simplify provisions where possible.

With input from stakeholders over the next 2 to 3 years, the MHRA intends to develop a medicines legislative framework which is comprehensive, comprehensible and fit for current purpose. At the same time, where possible, the MHRA hopes to reduce legislative burdens without compromising on the protection provided by legislation.

The main focus of this review will be on national legislation. European Union legislation is included in the scope of the project, in terms of rationalising the form of the legislation, but the MHRA will not be able to make any substantive changes, other than where it contains national discretions.

COMMENTS ON
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)
CONCEPT PAPER ON THE PROJECT TO CONSOLIDATE AND REVIEW MEDICINES LEGISLATION

The Royal College of Physicians of Edinburgh is pleased to respond to the MHRA on its Concept paper on the project to consolidate and review medicines legislation.

The College welcomes the opportunity to give early views on these proposals and has the following comments:

1. It is appropriate to undertake a review of Medicines Legislation at this time.

2. The College welcomes the general thrust of the proposals, notes their existing complexity and accepts that the review will largely address those aspects of the current legislation which are under national control.

3. The use of the new Legislation Reform Order is an appropriate way forward. However, as emphasised in Para 10, it is crucial that any significant and/or substantive changes proposed to the general thrust of the legislation should be incorporated into law only following a review by Parliament. We believe that no major changes of substance should be enacted without parliamentary approval.

4. The proposed structure of the Order under the Legislative and Regulatory Reform Act 2006 is appropriate and supported by the College.

5. In part 8 (annex B) it is discussed whether issues of classification of medicines into Prescription Only Medicines (POMs), Pharmacy only Medicines (Ps) and General Sales List Medicines (GSLs) should be dealt with separately. Whilst the College can see the sense in this (given the regular changes required in the appropriate Orders resulting from licensing new medicines) it will surely be necessary to incorporate a general (non-product specific) summary of the overall classification of medicines into three distinct and mutually exclusive categories at this point in the proposed Order.

6. The overall approach identified in Annex D is supported by the College. In so doing, we would emphasise several key issues of recurrent major importance:

• Clinical Trials – Current legislation, or perhaps more accurately, the current application of existing legislation is immensely tedious, bureaucratic and time wasting. There is extensive evidence that it is driving clinical trials work away from the UK, sometimes to other, newer, EU states, and often to non-EU countries. This would be appropriate were there any evidence of poor standards being applied in this country in the past; however, no such evidence has been forthcoming. The College believes that this opportunity should be taken to reduce significantly the bureaucratic burden on companies and individual investigators commencing and undertaking such trials in the future, paying particular attention to the huge, often inappropriate, demands made on investigators conducting multi-centre studies and/or studies of existing licensed products.

• Granting Marketing Authorisations (MA) – The suggestions here are worth pursuing. However, it is likely that the numbers of UK-only marketing authorisations will reduce rather than increase in the future and hence this aspect should not take up excessive time in the review.

• Suspend, revoke or vary a Marketing Authorisation – It is crucial that the existing provision for the Licensing Authority to suspend revoke or vary a marketing authorisation remains and that the relevant appeal mechanisms remain intact. In this regard, the College notes the phrase ‘…. This includes a procedural system of notification and hearing before an appointed person when required ….’. The College believes that heretofore such hearings were heard before a statutory body (eg the Medicines Commission) and not a single individual. We believe that such hearings should always be before a panel of relevant people and not just a single individual.

• Product Licences of Right - The College believes that we should move towards eliminating the old Product Licences of Right (PLRs) over a suitable time frame and have all such products, homeopathic and herbal, incorporated into alternative registration procedures.

• Exemptions – This area does indeed need reviewed, and it is difficult for the College to comment upon individual aspects until more detailed information is available. There are concerns about the situation of members of the Armed Forces in times of conflict receiving multiple vaccinations and other products of varying marketing authorisation status. This area needs review. The possibility of members of the forces being recipients of multiple licensed or unlicensed products within a short period of time with or without their consent needs active review. Such a review probably falls within this category of the Act but would also require work to be done in co-operation with the Department of Defence.

• Unlicensed Medicines - The College strongly supports the ongoing review of unlicensed products and their use, being particularly concerned about the possibility of certain manufacturers circumventing the provisions of the Medicines Act by this route. Some method of collating the use of such products locally (presumably by information collected by hospital and retail pharmacists) and evaluating it nationally is long overdue. A similar yet much more difficult area to police is the importation for sale or use of medicines ordered from abroad via the internet. The extent of such use is unknown at present and may constitute a significant public health hazard. Some effort to clean up this area would be of benefit were it possible as part of this review.

• Advertising – The College accepts the view that this aspect of the regulations requires a simple exercise only. However, we are strongly opposed to the possibility of direct advertising of prescription only medicines (POMs) to the public and would be firmly against any such development arising as a consequence of this review.

• Pharmacovigilance – The College notes and accepts the definitions of pharmacovigilance given here. It is vital that applicants have compliant pharmacovigilance systems and that these are not affected by a change of ownership of the company.

  The College agrees that the suggestion to base the proposed pharmacovigilance procedures for UK-only marketing authorisation applications should as far as possible be based on the European Decentralised Procedure.

  However, the College is concerned that the costs of ever increasing post-marketing procedures are showing no signs of being alleviated by decreasing the cost- and logistic- burdens of pre-marketing studies as was originally envisaged when post-marketing surveillance first came into being.

  Furthermore, the proposal that every time a change of ownership of a Marketing Authorisation takes place, the new holder will be required to submit a detailed description of their pharmacovigilance system for the product is inappropriate and excessively bureaucratic. This procedure will be necessary for some products but quite unnecessary for others, especially those products already in long term use whose safety profiles are well understood. The new MA holder surely can be left to submit any new data received by them at the time of regular review of the product safety profile.

  The College is concerned at the increasingly heavy burden of routine post-marketing safety monitoring costs imposed upon the pharmaceutical industry at a time of economic hardship and the far from adequate evidence that these costs are appropriate in the light of the results obtained.

• Random Inspections and Searches - The College would support the MHRA in any tightening of the powers to permit random inspections and searches to deal with situations of possible counterfeit and/or adulterated medicines to bring them into line with the powers of, for example, the Veterinary Medicines Directorate. Indeed, the College is surprised and concerned that such disparities have arisen, presumably since the abolition of the Medicines Commission and total separation of the management of human and veterinary medicines licensing systems.

• Sanctions - The use of terms in the draft document such as ‘supplying a medicinal product which can cause serious harm’ and ‘possession of a POM with intent to supply otherwise than in accordance with appropriate prescription’ are inappropriate and could easily be misinterpreted. Sanctions require great caution in the way in which they are framed. All POMs have the potential to cause serious harm if used inappropriately as well as resulting in great benefit when used appropriately (eg Chemotherapy). Likewise, the term ‘appropriate prescription’ is far too loose for comfort and anyway is inappropriate for a legal document. Clinicians are best placed to decide upon issues of ‘appropriate prescribing’, not lawyers and legal documents.

  The College is concerned about the increasing use of terms such as ‘name and shame’ in government papers. This has shades of ‘kangaroo courts’ and ‘summary justice’ about it and is inappropriate in legal documents. The named persons may have neither recourse to appeals nor the ability to clear their names or vindicate their actions thereafter. These proposals carry the risk of being unfair to the accused individuals or companies and require careful review.

  The College is also concerned about the comment in this section: ‘consideration will also be given to providing provision for “lesser” offences’: just what type of offences are envisaged here and can we be reassured that they will not be promulgated by officials with no real understanding of the difficulties in prescribing in the 21st Century? The College would like to have the facility to review any such proposals before they are incorporated into law, especially if the route of such incorporation envisaged is by Legislative Order and not via standard parliamentary procedures.

• Adulteration of medicinal products – this, including herbal products, remains an important issue and should be included within the review

• Unlicensed medicines – again, this remains an important issue and the College welcomes its inclusion within the review (see earlier comments).

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

[20 March 2009]