Pharmacy law veteran David Reissner says ‘the speech from the throne’ includes two pieces of legislation that will affect pharmacy practice…

The Queen’s Speech on May 11 announced two pieces of legislation that will affect pharmacy practice. A Health and Care Bill which is expected to implement the proposals in the Government’s earlier White Paper entitled Integration and Innovation, and there will be a Professional Qualifications Bill.

Integration and Innovation aims at: “joined up care for everyone in England. Instead of working independently every part of the NHS, public health and social care system should continue to seek out ways to connect, communicate and collaborate so that the health and care needs of people are met.”

The details of the Health and Care Bill have not yet been published, but below are some of the key features of the White Paper that may find their way into a Health and Care Bill:

Integrated Care Systems

Integrated Care Systems (ICSs) will be made up of an ICS NHS Body and an ICS Health and Care Partnership. The Government believes ICSs will “strengthen the decision making authority of the system leadership and…embed accountability for system performance into the NHS accountability structure.”

According to the Government, this dual structure recognises two forms of integration: integration within the NHS to remove some of the “cumbersome barriers to collaboration and to make working together across the NHS an organising principle”.

The new ICS NHS body will be responsible for:

  • Developing a plan to meet the health needs of the population within their defined geography
  • Developing a capital plan for the NHS providers within their health geography
  • Securing the provision of health services to meet the needs of the system population
  • Taking on the commissioning functions of the CCGs and some of those of NHS England within its boundaries.

Forging partnerships

ICS NHS bodies will be responsible for establishing ICS Health and Care Partnerships, bringing together health, social care, public health (and potentially representatives from “the wider public space where appropriate”, such as social care providers or housing providers).

These partnerships will be responsible for developing a plan that addresses wider health, public health and social care needs, with the ICS NHS Body and Local Authorities being required to have regard to that plan when making decisions.

Duty to collaborate

There will be a new duty to promote collaboration across the healthcare, public health and social care system. NHS bodies that arrange NHS Services will be required to protect, promote and facilitate patient choice with respect to services or treatment.

Where there is no value in running a competitive procurement process, services can be arranged with the most appropriate provider.

Public Health England came under heavy criticism in the early days of the COVID-19 pandemic. The Bill will create the National Institute for Health Protection (NIHP). Amongst other things, NIHP will take over the functions of Public Health England.

Professional regulation

The Government is still considering responses to a recent consultation on the reform of healthcare regulation. It is not clear whether the Government will be ready to include reforms in the Health and Care Bill, though proposals are included in the White Paper. These proposals include:

  • Changing the structure of the bodies that regulate healthcare.
  • Powers to reduce the number of regulatory bodies The GPhC is one of ten healthcare bodies regulated by the Professional Standards Authority. The Government believes that a reduction in the number of regulators, for example by merging some of them, would “deliver public protection in a more consistent way, while also delivering financial and efficiency savings.”
  • Enhancing the powers of some regulators. The GPhC is one of the newest regulators and it already has some of the most modern powers, but changes are likely, even if they do not make it into the impending Health and Care Bill.

Medical examiner

Following the recommendations of successive inquiries, including the Shipman Inquiry, an NHS statutory medical examiner system will scrutinise all deaths which do not involve a coroner.

There will be a new, unified system of death certification in England.

NHS bodies, rather than local authorities, will appoint Medical Examiners. Every death in England and Wales will be scrutinised, either by a coroner or a medical examiner.

The medical examiner system is intended to improve the accuracy of the cause of death and subsequently mortality statistics and will increase transparency for the bereaved and help deter criminal activity and poor practice.


Medicines registries

The MHRA will be able to set up medicines registries to consolidate prescribing data for specific medicines with data from clinical care and other social administrative databases, and can be further developed to capture more detailed and bespoke data on the cohorts of patients receiving these medicines.

The data captured in a specific medicine registry may help support the safe use of the medicine.

Registries would be established for a medicine where the public need is clear and the benefits of a publicly held national registry that can access routinely collected data are required.

Registries may be used where a medicine is known to carry a risk of serious adverse health outcomes and consistent adherence to risk minimisation measures is critical, or where there are substantive unknowns about the safety or effectiveness of a medicine in a population and urgent evidence is required to support safe access to it.

Qualifications bill

Pharmacists who qualified in the EU and who were already registered with the GPhC by 30 December 2020 retain their registration.

Pharmacy technicians could not benefit from EU mutual recognition arrangements because not all EU states recognise the profession of pharmacy technician.

Post-Brexit arrangements for recognizing professional qualifications are needed. The Professional Qualifications Bill has already been introduced in the House of Lords. When the Bill becomes law, the GPhC and other professional bodies will have new powers to recognise professionals who qualified overseas, and this power will extend to all pharmacy professionals.

David Reissner is chair of the Pharmacy Law & Ethics Association.

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