Post-Implementation Review of the Human Medicines Regulations 2012
Published: 09/05/24
Consultation Response: Post-implementation review of the Human Medicines Regulations 2012
Introduction
The MHRA have a statutory duty to carry out regular reviews of specific parts of the Human Medicines Regulations (2012). The first and only review to date was carried out in 2017 – the final report of this review can be found here. Although the same areas of the regulations are being reviewed as in 2017, we are now in a post-Brexit era, and there have been some amendments to the regulations in the intervening years.
To inform the next report, the MHRA have published a questionnaire. Our response is included below – please note that not all areas are relevant to community pharmacy, so some questions have not been answered – notably in the Falsified Medicines Directive section, which is not asking about the community pharmacy element of the regulations.
Section 1: Pharmacovigilance
The HMRs implemented national requirements of EU PV legislation, Directive 2010/84/EU, key objectives of which included:
Rationalising EU decision-making on drug safety to deliver measures that are equally implemented across the community.
Strengthened PV systems, allowing continuous improvement while reducing administrative burden.
Greater communication to increase understanding and trust of patients and health professionals.
Since the last Review, regulations have been amended to reflect the UK’s Exit from the EU and the requirements with regards to the supply of human medicines to Northern Ireland. Amendments include changes that apply to UK marketing authorisation holders regarding PV practices.
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Completely met
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Vastly improved
From a community pharmacy perspective it is clear that, since 2012, the improved PV requirements have had a significant impact on patient safety. Prior to implementation, it was rare to see a marketing authorisation or even side effect profile of a well-established drug change, but this is now commonplace thanks to ongoing monitoring and supports pharmacists in promoting the safe use of medicines.
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Unsure
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N/A
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No
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Unsure
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Unsure
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Yes
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No
Section 2: Cross Border Prescriptions
Objective: The HMRs, as amended in 2019, have enabled dispensing healthcare professionals to dispense certain prescriptions written outside the UK if it was written by a member of a listed profession and written in a listed country, and otherwise meets the requirements in the HMRs.
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Beneficial & Detrimental
For patients who live or work across more than one country, the implementation of recognition of cross-border prescriptions has undoubtedly provided a benefit. For patients electing to undergo procedures in countries other than where they live, this has also made pre- and after-care much more straightforward (for example: fertility, cosmetic and bariatric procedures).
However, this feature of the HMRs has also led to the proliferation of online business models which offer prescribing services to UK residents from prescribers who are not regulated in the country. Whilst some have robust governance arrangements and deliver a valid alternative route to care for UK patients, our experience is that many do not. These services can put vulnerable patients at great risk.
One example from recent years was a service based in Spain, using prescribers across Europe. This service repeatedly wrote prescriptions for opioids for a patient without any discussion with or notification to their GP – these were taken to various pharmacies so there was no central record of the supplies. When concerns were eventually raised about the patient, the service cut all ties and abruptly stopped prescribing, creating an urgent need for support from the NHS.
The answer to these concerns does not necessarily lie in changing the HMRs, but perhaps in the regulation of services which are not UK-based but offer prescribing services into the UK.
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Beneficial & Detrimental
As per our answer to question 1, there are circumstances where being able to dispense against a prescription from a prescriber in another country makes the patient journey and the pharmacist’s processes much more straightforward than they were pre-implementation. This is, however, not always the case. Few of the countries listed in the 2019 amendment have easily accessible prescriber registers for all of the approved professions – so validating the legality of prescriptions can be very challenging, as can safe translation.
Following on from our comments about non-UK businesses providing prescribing services into the UK, the pharmacist can often be put in a challenging position professionally. Even where a prescription is assessed as being legally valid, making an assessment of clinical suitability can be near-impossible. Pharmacists have to make decisions on whether it is more harmful to supply than not with very little information available to support the decision. In the middle of all of this are patients who have been set up with an expectation of a supply and have paid for a service in good faith. A recent example of this is in the arena of transgender healthcare, where very young patients have presented prescriptions for puberty blocking drugs which have been written by prescribers who are not registered or regulated in the UK.
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Please see our answer to question 2.
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Unsure
We cannot speak for other healthcare professionals, but an observation would be that those who can prescribe are now able to offer their services online to a wide audience, which we would perceive as a benefit.
However, those working within the NHS in the UK now have the additional burden of supporting patients whose care has been less than satisfactory.
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Please see our answer to question 4
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Somewhat increased burden
In principle, being able to dispense routine prescriptions from a patient’s regular prescriber/prescribing service which happens not to be based in the UK is a positive, and reduces the burden on the patient and the dispenser.
However, the lack of regulation of businesses whose model is to proactively offer prescribing services into the UK using non-UK prescribers creates a significant burden on patients, pharmacists and the NHS. The numbers may not be high in relative terms, but each instance inevitably requires a lot of attention and time to safeguard our patients.
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Improved regulation of businesses which offer prescribing services into the UK predominantly using non-UK prescribers.
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Unsure
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N/A
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No
Technology and healthcare consumer behaviour have moved on since 2012. We believe that either the policy objective should be narrowed or further regulation should be introduced to mitigate the risks we have raised in our previous answers.
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No
Even with the current level of regulation, there have been significant unintended patient safety risks introduced as a result of the cross-border elements of HMR 2012 being implemented.
Section 3 - Sale and Supply: Exemptions for certain collection and delivery arrangements
Exemptions for certain collection and delivery arrangements (regulations 248(1)(a) and (2)(a)
“Collection and delivery arrangement” means an arrangement whereby a retail pharmacy may take or send a medicine to be supplied in accordance with a prescription given by a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber, physiotherapist independent prescriber, podiatrist independent prescriber, therapeutic radiographer independent prescriber, paramedic independent prescriber or optometrist independent prescriber for collection from premises other than a registered pharmacy and which are capable of being closed by the occupier to exclude the public.
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Improved
Patients who do not (through geography or circumstance) have easy access to medicines supplies have benefitted from the implementation of this regulation. This said, in most cases, the regulation merely reaffirmed the validity of arrangements which had been in place to support these groups of patients for some time.
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Don’t know
Please refer to our answer to question 3 in this section.
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Yes
Whilst the policy intent of regulation 248 is to improve access to prescribed medicines where this is perceived to be lacking (e.g. in rural areas), we have started to see the exemption used to improve market share in areas where pharmaceutical care service provision is not lacking.
It is too early to tell what impact these arrangements will have on patient safety, but our position would be that the exemption is just that – an exemption from the norm to meet specific patient needs, and not a ‘new normal’ in the dynamics between patient and pharmacist.
Section 4 – Sale and Supply: Repeal of Section 10(7)
Repeal of Section 10(7) [regulation 349 in so far as it repeals section 10(7) of the Medicines Act 1968]
Section 10(7) of the Medicines Act 1968 provided an exemption in UK law for the requirement for a pharmacist to hold a Wholesale Dealer’s Licence if the wholesale dealing formed only a minor portion of their business at that pharmacy. The repeal of section 10(7) was necessary to comply with EU legislation, in particular articles 77(1) and 77(2) of Directive 2001/83/EC which required anyone undertaking wholesale dealing activities to hold an authorisation.
In doing so, the objective of the HMRs was to:
Take account of the UK’s National Health Service (which is relatively unique among Member States as a health service open to all without the need for private insurance).
Protect patients by assuring the security of the supply chain.
Preserve continued supplies of medicines above all other concerns.
Minimise extra regulatory cost and administrative burden, particularly for the NHS.
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Weakened
The net effect of the repeal is that fewer appropriate supplies are being made, driven by uncertainty around the guidance and what constitutes a supply exempt from WDL requirements.
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Detrimental
The move from a defined level of acceptable wholesale dealing to the four criteria for exemption has been challenging for some of our members.
Those who engage in a reasonable volume of wholesale dealing as part of their business are largely unaffected, as they would always have required a WDL.
On the other hand, those who do not often make supplies can find it difficult to determine whether a given transaction is exempt or not due to the vague nature of the criteria. In our experience, many default to not making a supply, which can have an impact on other health professionals and ultimately patients.
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Detrimental
As per our answer to question 2 in this section, other healthcare professionals can find that their requests for supplies are not met – and they will often find variation between pharmacies and pharmacists, causing confusion.
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Somewhat increased burden
Although the number is small, the repeal has led to some business taking on the costs and associated burden of obtaining and maintaining a WDL. These businesses may not be undertaking any more activity than they were prior to the repeal, and were already ensuring patient safety by meeting their existing regulatory requirements.
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Pharmacies being able to make small, infrequent supplies to businesses and healthcare professionals is essential to the running of the NHS and the contractors it relies upon – as well as the private businesses that look after NHS patients in other ways.
The policy objective of the guidance recognises this and as such is still relevant, however in practice the nature of the guidance is preventing the very supplies it is designed to enable.
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Yes
As per our previous answers in this section, the guidance in place is only partially meeting the policy objective.
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Somewhat increased burden
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Yes
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No
We believe it is the guidance which needs strengthened to give pharmacists more confidence as to what the policy intent is, and more understanding as to where ‘the line’ is with regards to needing or not needing a WDL.
Section 5: Falsified Medicines
Implementation of the Falsified Medicines Directive (FMD)
Provisions: Chapters 1, 3 and 4 of Part 3; Part 12A; Regulations - 18(6); - 37(4)(b), (5), (6) and (12); 43(5), (6)(a) and (d), 7(c)(iii) and (vii), (8) and (10) to (14); 44(2) to (6), 110(8A); 135(10A); 330(1) and (2); Schedule 5 paragraphs 1(1)(b) to (d), (2)(b) to (d), 3(11)(b)(vi) to (viii), 5(2)(f) to (h) and Schedule 7A
Objective: The EU FMD (2011/62/EU) was adopted in the UK in 2013 with the final part of the Directive, the ‘safety features’ coming into force in 2019.
It was applied to maximise the protection of the legal supply chain in the EU against infiltration of falsified medicinal products, i.e. to ensure that for all practical purposes the possibility that medicinal products purchased in the legal supply chain in the EU are counterfeit can be practically ruled out. Measures included:
Tougher rules on import of active pharmaceutical ingredients
Strengthened record-keeping requirements for wholesale distributors.
Many of the provisions, which relate to FMD, built on existing obligations on those who trade in medicines (manufacturer and wholesale dealers). The legislation also extended to previously unregulated operators such as those engaged in brokering the sale and supply of medicinal products.
Since the UK has exited the EU, the ‘safety features’ (serialisation) part of the FMD ceased to have effect in Great Britain from 31 December 2020 and will be disapplied in Northern Ireland when the Windsor Framework takes effect on 1 January 2025.
We are therefore not looking for input on the implementation of the ‘safety features’ and verification provisions, given that these will not apply in any part of the UK from 1 Jan 2025. We are looking for input on the other changes to the HMRs that were originally made as a result of FMD, and remain in place.
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N/A
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N/A
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N/A
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N/A
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N/A
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N/A
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N/A
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N/A
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N/A
Section 6: General
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No
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N/A
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No
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N/A
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N/A
Reporting to the Area Support Pharmacist, you will be responsible for and oversee the delivery of all aspects of the Scottish Pharmacy Contract and optimise the delivery of dispensing and professional services.