Introduction
1. We are writing to consult you, in accordance with section 129(6) of the Medicines Act 1968, on proposals to amend the Human Medicines Regulations 2012 to enable Public Health England (PHE) to develop and authorise Patient Group Directions (PGDs).
2. This proposal is intended to strengthen the health protection response to outbreaks of infectious disease and other incidents through extending the use of PGDs to staff employed by Public Health England (PHE). The aim is to ensure that in the event of an incident or outbreak PHE staff can take the appropriate rapid action to respond or to control the spread of disease. Although supplying/administering vaccines and medicines during incidents and outbreaks will remain primarily an NHS responsibility, enabling PHE to authorise its own PGDs and specified PHE health professional staff to supply and/or administer vaccines and medicines under PGDs, will support the NHS response where necessary, and strengthen the resilience of the public health system.
3. This consultation abides by the principles set out in the Cabinet Office’s revised guidance for Government departments and other public bodies:
Application to England, Wales, Scotland and Northern Ireland
4. This consultation letter has been produced jointly by the Medicines and Healthcare products Regulatory Agency (MHRA), Public Health England and the Department of Health and the Public Health Agency (PHA) /Department of Health Social Services and Public Safety (DHSSP).As the proposals are limited in scope and the use of PGDs is well-established, we think a six week consultation period is proportionate.
5. Although medicines legislation applies throughout the United Kingdom, the proposed changes, if adopted, would relate solely to PHE’s and PHA’s responsibilities.
Royal College of Physicians of Edinburgh Consultation response
Medicines and Healthcare Products Regulatory Agency (MHRA) – MLX 388: Proposals for Amendments to Human Medicines Regulations 2012 to enable Public Health England to Develop and Authorise Patient Group Directions
The Royal College of Physicians of Edinburgh (the College) is pleased to respond to the call for views on proposals for amendments to Human Medicines Regulations 2012 to enable Public Health England to develop and authorise Patient Group Directions.
i. Do you agree with the proposal to include PHE and PHA in the list of authorising bodies under the provisions in medicines legislation relating to Patient Group Directions? If not, why not?
Yes, the College would agree with this, in exceptional circumstances only. It should not be seen to replace existing usual mechanisms via the NHS. We would appreciate it if further clarification was available as to how it is proposed to ensure this will be by exception only and will not become routine.