The government is consulting on legal changes that would assist the distribution of coronavirus and flu vaccines, by amending the exemptions to various criminal offences. John Binns looks at the detail.
What does the law say now?
The regulation of medicinal products in the UK is a complex affair, largely governed by the myriad provisions of the Human Medicines Regulations 2012 (the HMRs). In broad terms, there are a number of activities that are subject to criminal liability (punishable with up to two years' imprisonment) unless both the person doing them, and the product they are doing it with, are licensed, unless certain exemptions apply. In practice, this enables the intervention of the regulator, which (in England and Wales) is the Medicines and Healthcare products Regulatory Agency (the MHRA).
Prohibitions on unlicensed wholesale dealing etc
The activities covered by the HMRs include wholesale dealing in medicinal products1 (with limited exemptions, principally for manufacturers2), as well as brokering3, importing, manufacturing, and distributing4 them.
The sale or supply of unlicensed medicines, and 'specials'
The HMRs also ordinarily prohibit selling or supplying medicinal products that are not licensed5, although importantly, there is an exemption for the sale or supply (by someone with a licence) of products that the MHRA has authorised on a temporary basis ('specials'), which it may do in response to (among other things) the spread of pathogenic agents6.
Restrictions on the sale or supply of medicines
The HMRs also impose restrictions on the sale or supply of (even licensed) medicinal products (with criminal liabilities for breach) in three categories: prescription-only7; 'not subject to general sale'8 (broadly speaking, the products sold by pharmacists); and 'subject to general sale'9. All of these are subject to various exemptions, including while a disease is pandemic, if the sale or supply is in accordance with a protocol approved by ministers or an NHS body10.
Restrictions on the advertising of medicines
Finally, the HMRs prohibit (in broad terms) the advertising of unlicensed medicinal products11, and impose restrictions (again, with criminal liability for breach) on the advertising of medicinal products generally, although some of these do not apply to vaccination campaigns approved by ministers12.
What changes is the government proposing?
At the time of writing the government is consulting on various amendments to the HMRs.13 These are expressed as for the purposes of its response to the coronavirus pandemic, although some also have a broader application.
Unlicensed wholesale dealing in vaccines, or under a pandemic protocol
With respect to the prohibition on wholesale dealing without a licence, it is proposed that this will not apply where the product is either a coronavirus or flu vaccine, or distributed under a pandemic protocol, and the dealing is (broadly speaking) done under NHS arrangements.14 (There are no such proposals with respect to brokering, importing, manufacturing, or distribution.)
Conditions on temporary authorisations of medicines ('specials')
With respect to the prohibition on selling and supplying unlicensed products, it is proposed that where the MHRA authorises medicinal products ('specials') on a temporary basis, this can be subject to conditions, so that the exemption would not apply where those conditions are not met.15
Protocols to disapply restrictions on the sale or supply of medicines
With respect to the restrictions on the sale or supply of medicinal products generally, two proposals are made. The first is that the existing pandemic protocol that could disapply these restrictions would no longer be required to specify the symptoms of the disease; instead, it would have to specify how the product would be used to prevent it16. The second is that the restrictions could also be disapplied by new protocols relating to flu and/or coronavirus vaccines during a pandemic17.
Advertising of 'specials' and other medicines as part of a government campaign
With respect to the prohibition on advertising of unlicensed medicinal products generally, it is proposed that this will not apply to products the MHRA has authorised on a temporary basis, if part of a campaign approved by ministers.18
With respect to the restrictions on advertising of medicinal products generally, it is proposed that some of these will not apply to campaigns approved by ministers relating to the use of products in response to (among other things) the spread of pathogenic agents.19
Is this a genuine consultation?
The government has made clear in its consultation that it is primarily interested in responses from experts in this field, rather than the general public, citing both the potential urgency of the issues and the technical nature of the proposals. It is undoubtedly true that medical experts and major participants in the pharmaceutical industry will be best placed to respond, as few others will be familiar with the intricate detail of the HMRs.
It is also surely true, however, insofar as the purpose of the prohibitions and restrictions of the HMRs is to protect the public from harm, that any proposals to amend them are deserving of wider attention. In due course, assuming the proposed amendments to their provisions come into law, they may have important effects both on the businesses and professionals that have to comply with them, and on the patients and wider public that they are designed to protect.
Footnotes
1 Human Medicines Regulations 2012, Regulation 18
2 Regulation 19
3 Regulation 45A
4 Regulation 45M
5 Regulation 46
6 Regulation 174
7 Regulation 214
8 Regulation 220
9 Regulation 221
10 Regulation 247
11 Regulation 279
12 Regulations 280 to 297
13 https://www.gov.uk/government/consultations/distributing-vaccines-and-treatments-for-covid-19-and-flu
14 Draft Human Medicines (Coronavirus) (Amendments) Regulations 2020, regulation 4 (amending HMRs Regulation 19)
15 Draft regulations 5 and 6 (amending HMRs Regulation 41 and inserting a new Regulation 174A)
16 Draft regulation 13 (amending HMRs Regulation 247)
17 Draft regulation 14 (inserting into the HMRs a new Regulation 247A)
18 Draft regulations 17 and 18 (amending HMRs Regulations 279 and 280)
19 Draft regulations 19 to 24 (amending HMRs Regulations 281 to 291 and inserting a new Regulation 291A)
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