PDA respond to the DHSC’s Informal consultation on urgent changes to the Human Medicines Regulations 2012

Prompted by the preparations for the UK’s exit from the EU, the Department of Health and Social Care (DHSC) is proposing some changes to the Human Medicines Regulations 2012 to ensure the continuity of the supply of medicines when the UK leaves the EU, including in a ‘no deal’ scenario.

Tue 8th January 2019 PDA Union

The DHSC is proposing to bring about the following:

  • Medicines substitutions by a pharmacist in accordance with a Serious Shortage Protocol (which would apply irrespective of whether or not the UK leaves the EU)
  • Ministers being able to modify the Human Medicines Regulations to deal with serious medicines shortages.

The PDA understands the need to introduce provisions to enable supply by a pharmacist in accordance with an SSP, in the event of a no-deal Brexit, and broadly agrees with the provisions in that regard, set out in the draft legislation introducing section 226A of the Human Medicines Regulations 2012.

However, the government appears to have overlooked the fact that other areas of legislation would also need to be amended in order to make it lawful for a pharmacist to substitute medicine. These include at the very least:

  • The Human Medicines Regulations section 17 (assembling not in accordance with a prescription)
  • The Medicines Act 1968 Section 64 (supply of a medicine not of the nature or quality demanded).

The PDA is also concerned about the proposals to allow Ministers to “modify the application” of nine of the seventeen parts of the Human Medicines Regulations 2012 by Ministers, including but not limited to the “sale by a pharmacist in accordance with an SSP” provisions set out in the same consultation. If the application of the law is modifiable, then it seems for all intents and purposes, the law itself is modifiable.

The PDA expressed concerns about these proposals, including:

  • This amendment would transfer a significant amount of power from parliament to Government Ministers, which would have significant constitutional implications in relation to medicines.
  • The consultation states that the introduction of section 344B would only come into force in a ‘no deal’ Brexit scenario. However, on reading the actual statute, these powers would be in effect in the event of any Brexit at all.
  • These powers could make it possible to sanction medicines supply to patients in non-pharmacy locations in the absence of any pharmacist input or usual safeguards, for reasons which are not even predominantly related to withdrawal from the EU.
  • This could pose a risk to patient safety and would open the door to governmental interference in medicines supply in the absence of the usual parliamentary involvement and oversight.
  • It will be time-consuming for front-line staff to explain to patients the changes to their medication where a medicine substitution is needed, and pharmacists will need to liaise with GPs about the changes to ensure continuity of care. We were concerned by the government’s view that no such pharmacist/GP liaison would be required and that as a result, the changes would amount to a “positive impact”.

Download the PDA’s full response here

thumbnail of Informal consultation on urgent changes to the Human Medicines Regulations 2012 final

The draft amended regulations can be found here

thumbnail of Draft regulations 226A and 344B PDF

The DHSC’s consultation letter can be read here

thumbnail of Medicines Shortages Brexit Consultation

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