Draft Human Medicines (Amendment Relating to Original Pack Dispensing) (England and Wales and Scotland) Regulations 2023

Karin Smyth Excerpts

Tuesday 5th September 2023 General Committees

[Karin Smyth (Bristol South) (Lab)]

It is a pleasure to serve under your chairship, Ms Nokes. The Opposition are supporting the regulations because they clearly represent the right thing to do for patients and constituents. Not only do they improve patient safety, which must be our priority, but they increase flexibility for pharmacists and patients alike. I am also pleased that valproate has been given due attention in this SI, following the important work by Baroness Cumberlege in the independent medicines and medical devices safety review; it is just a shame that it has taken two years following the Government’s own consultation on this matter to introduce this legislation.

Campaigners have long argued that it is key that medicines containing sodium valproate should be dispensed in the original manufacturer’s packaging to ensure that women and girls, particularly those of child-bearing age, always receive patient information about taking the medicine while pregnant. As we know from the many tragic impacts of foetal valproate spectrum disorder on our constituents and people around the country, this SI is long overdue. I pay tribute to those campaigners.

As the Minister would expect, I have some questions. The Medicines and Medical Devices Act 2021 requires that, when assessing whether regulations would contribute to the objective of safeguarding public health, the appropriate authority must have regard to three factors, one of which is the availability of medicines. It appears to me that the SI misses the opportunity to address the current shortage of medicines, including of those involved in hormone replacement therapy—something that has affected many women across the country.

Section 64(5) of the Medicines Act 1968 prohibits the sale or supply of a medicinal product where that product is not of the nature or quality specified in a prescription—for example, if a pharmacist dispenses two 50 microgram tablets against a prescription calling for a 100 microgram tablet, when the 100 microgram product is in short supply. The SI allows the dispensing of 10% more or less than the quantity prescribed of a medicine. Given that the SI is about flexibility, and given the campaigning on this issue, particularly by women, this could have been an opportunity to look again at packaging; women could then get the drugs that they are prescribed.

The professional judgment of pharmacists will remain a critical part of the dispensing process for all medicines. I am pleased that guidance on whole-pack dispensing of medicines containing valproate will be provided by the Medicines and Healthcare products Regulatory Agency before the instrument comes into force. What other support and guidance will be given to pharmacists to ensure that the SI is implemented effectively? Will the Minister give an indication of the timeline for the consultation on Pharmacy First, given that it is due to be implemented by the end of this year? Can she tell us about the contractual restrictions relating to NHS prescriptions? As I understand it, reimbursement is based on the exact product prescribed. Forgive me if I missed it, but I do not think that she addressed that issue.

Finally, I appreciate the publication of an impact assessment alongside this SI, but the section on reimbursement gives two alternative scenarios: either reimbursement based on the quantity written on the prescription, or reimbursement based on what was dispensed, rather than what was written on the prescription. Those necessarily have different impacts on the cost to pharmacies and the wider NHS. If the Minister could provide clarity on those issues, I would be grateful.