The MHRA's Review of the Human Medicines Regulations 2012
The UK's Medicines and Healthcare products Regulatory Agency has reviewed the implementation of the Human Medicines Regulations 2012. The Agency considers that, on balance, the Regulations represent a sound consolidation of complex medicines legislation. However, certain aspects of the Regulations require further work and this may result in additional guidance being issued by the MHRA (e.g., on cross-border prescriptions and wholesale dealing). Measures to encourage work-sharing between marketing authorisation holders in relation to pharmacovigilance obligations may also be adopted by the MHRA.
Background and summary
On 5 December 2017 the UK's Medicines and Healthcare products Regulatory Agency (MHRA) published a Post-implementation Review of the Human Medicines Regulations 2012 Review).
The Review assesses the effectiveness and impact of the Human Medicines Regulation 2012 (2012 Regulations), which were introduced in the UK with a view to implementing a series of EU directives and to consolidate UK medicines legislation. The Review also sets out recommendations about how to address shortcomings identified in the 2012 Regulations.
The obligation to carry out a review of the 2012 Regulations is set out in regulation 346. The focus of the review was on the principal changes introduced by the 2012 Regulations, comprising:
- The impact of the consolidation of the previous UK legislation;
- Implementation of Directive 2010/84/EU (Pharmacovigilance Directive);
- EEA cross border prescriptions; and
- The repeal of Section 10(7) of the Medicines Act 1968 (which provided an exemption for the requirement for a pharmacist in a registered pharmacy to hold a Wholesale Dealer's Licence if the pharmacy undertook wholesale trading in medicines in certain circumstances).
The 2012 Regulations are to be retained and, based on the Review, it seems that no major overhaul of these Regulations is to be expected. However, there are likely to be several pieces of guidance issued by the MHRA in the near future in relation to those aspects of the 2012 Regulations which have proved most controversial. It is hoped that these will provide welcome clarification. In addition, measures intended to ease the burden for manufacturers of generic medicinal products in relation to the maintenance and distribution of Risk Management Plans (RMPs) and Risk Minimisation Measures (RMMs) may be introduced shortly. The suggestion made by the MHRA in the Review is that work-sharing should be "encouraged" as between marketing authorisation (MA) holders, although some respondents to the consultation have suggested that work-sharing should be mandatory. It remains to be seen how, and in what form, the MHRA chooses to introduce any such new measures.
The issues identified above were the subject of a public consultation that ran from 15 June to 6 July 2017. Approximately 60 responses from a range of stakeholders were received. However, analysis of the consultation responses reveals that the majority of questions were skipped by responders. None of the consultation questions was individually addressed by more than 20 responders, and many questions were addressed by only a handful of responders. Owing to the low number of substantive responses to the consultation, it is arguable that the conclusions to be drawn therefrom are limited. Nevertheless, the Review relies significantly on the consultation to justify its analysis and recommendations regarding the 2012 Regulations.
Overall outcome and recommendations
The Review notes that, on balance, the 2012 Regulations represent a sound consolidation of fragmented and complex medicines legislation, presented in a simplified form to improve the coherence of the regulatory framework. However, the Review makes four recommendations. These are discussed in turn below.
- Obligations relating to RMPs and RMMs contained in the 2012 Regulations are a reflection of requirements contained in the Pharmacovigilance Directive. However, some consultation respondents point out that RMPs and RMMs are not always in the public domain. Even when these are accessible to applicants for generic (copy) products, documents submitted for assessment based on the originator's materials may have been assessed in an inconsistent manner, including by the MHRA. This has resulted in some MA holders having two or more RMPs for the same active substance. According to the responses received in the consultation, some MA holders for copy products consider the costs associated with RMM to be a barrier to market entry. The Review's Recommendation No. 1 is that, by March 2018, the MHRA is to have considered what more could be done to remove the potential barrier to market entry for such MA holders, arising from the current requirement to create and maintain RMPs and prepare and distribute RMMs. One option identified by the MHRA in the Review is to further encourage work sharing between MA holders.
- The consultation responses highlight several practical issues giving rise to increased workload for both prescribing healthcare professionals and pharmacists in connection with cross-border EEA prescriptions. Issues include inconsistent formatting of prescriptions from other EEA countries, prescriptions not written in English and prescriptions for medication not available in the UK. Verification of the prescription can also be time consuming. The Review's Recommendation No. 2 is that the MHRA shall review the guidance currently available to pharmacists and healthcare professionals on cross border prescriptions with a view to publishing by March 2018 a revised guidance to aid awareness and understanding.
- With regard to the repeal of Section 10(7) of the Medicines Act 1967, respondents to the consultation note that, although it may be reasonable to restrict wholesale dealing when it is being carried out commercially for profit, it has not been helpful to extend this restriction to the supply chain involving hospitals, pharmacies, and hospices. In the Review, the MHRA emphasises that there have been no reports of patients not receiving their medicines because of the repeal of Section 10(7). The Review's Recommendation No. 3 is that the MHRA shall consider concerns expressed in the consultation about the repeal of Section 10(7), and what further action might be appropriate (such as revised guidance). This will be completed by December 2018, to align with any new guidance on the safety feature element of the Falsified Medicines Directive coming into force in the UK.
- Lastly, the Review's Recommendation No. 4 provides that the MHRA shall (in consultation with NHS England and DH) consider an extension of prescribing responsibilities to particular groups of healthcare professionals operating in emergency care settings. The MHRA will also assess how best to publicise future amendments to the 2012 Regulations. This will be completed by March 2018 as part of the next set of amendments to the 2012 Regulations.
The big unknown hanging over the Review and its recommendations is the effect of the UK's decision to leave the EU, effective on 29 March 2019. For example, the consultation responses confirm that it is currently unclear what the implications of UK withdrawal are on cross-border EEA prescriptions. Unless there is immediate clarity on this issue, it may be difficult for the MHRA to provide anything more than short-term guidance by March 2018 (which is the deadline set for completion of Recommendation No. 2).
Depending on the extent to which UK law retains the EU pharmaceutical acquis following withdrawal, there may be opportunity to reassess those EU law-based requirements giving rise to concerns identified in connection with Recommendation Nos. 1, 2 and 3. For example, the UK's negotiation position in the lead up to finalisation of the Pharmacovigilance Directive was that RMPs should not be required for all MAs for generic products, but should instead depend on risk and the need for specific risk management. Following its withdrawal from the EU, it is possible that the UK could decide to reflect that position in domestic law. In so doing, the market access concerns of such manufacturers (discussed in connection with Recommendation No. 1) might be addressed, although it would be necessary to recognise the potential wider effects on market access of any decision which creates divergent pharmacovigilance requirements for the UK and EU respectively.
Lastly, it is arguable that the measure proposed in Recommendation No. 2 is unsuited to address the concerns identified in the consultation, which principally consist of practical issues associated with the processing of EEA generated prescriptions (e.g., inconsistent formatting, incomplete information, prescriptions for medicines not available in the UK). The MHRA plans to issue updated guidance to aid awareness and understanding of these requirements. However, there is no proposal to review and amend the rules themselves (to the extent such amendment would be consistent with EU law).
© 2017 Arnold & Porter Kaye Scholer LLP. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.