Guidance on key workers in the UK pharmaceutical industry
On Friday 20 March 2020, the Government released a list of key workers, whose children would be able to access continued educational provision at school. This includes those involved in the medicine supply chain within the following extract of the announcement:
Health and Social Care: “This includes but is not limited to doctors, nurses, midwives, paramedics, social workers, care workers, and other frontline health and social care staff including volunteers; the support and specialist staff required to maintain the UK’s health and social care sector; those working as part of the health and social care supply chain, including producers and distributers of medicines and medical and personal protective equipment.”
Ultimately, FPM members and their employers must exercise their own judgment in identifying key workers, as roles and requirements can differ from company to company. It is recommended that – roles which are critical to the safe development, production, testing, release, monitoring, and distribution of products, as well as roles which are key to the safety of patients (in the general population as well as trial participants) and staff – should be prioritised and fall within scope. This may include:
- Staff involved in the manufacturing and supervision of manufacturing of medicines and medical technologies. Clearly, companies will need flexibility to decide which individuals need to stay on site as part of the manufacturing process including warehousing, maintenance engineers, waste disposal operations, Sterility Assurance, GMP; cleaning operations and IT technicians.
- Staff involved in the distribution, supply and maintenance of medicines and technologies, and associated raw materials
- Key Regulatory and Quality staff who oversee the safe development, production, testing, release, monitoring and distribution of products. For example:
- Head of Production
- Qualified Person Responsible for Pharmacovigilance (QPPV), and patient safety
- Qualified Person to ensure medicines compliance & batch release.
- Head of Quality Control and staff involved in quality assurance and quality control of medicines.
- Responsible Person ensuring compliant warehousing and distribution of medicinal products
- Clinical Research Associates and other clinical staff who are working with the NHS to treat patients.
- Staff working in research and development and the maintenance and upkeep of facilities. This includes security staff and contract cleaners.
- Staff required for the health and safety of manufacturing sites and of supply chain.
- Staff involved in supporting animal facilities, to facilitate any necessary testing and ensure the highest standards of welfare are maintained.
Doctors in the UK with a licence to practice outside the NHS
We are expecting an announcement imminently from Celia Ingham Clark, Medical Director for Clinical Effectiveness, NHS England, regarding mechanisms for how doctors currently with licences to practise who work outside the NHS can volunteer their skills and experience in returning to clinical practice. We will update FPM members as soon as we have any further information.
The FPM recommends that independent pharmaceutical physicians use their best judgement as to where their own skills and knowledge are best put to use. This may be in their scientific capacity or by returning to clinical practice.
Pharmaceutical physicians who have relinquished their licence to practise or have retired and de-registered in the last three years may wish to consider pursuing voluntary temporary registration, as advised by the GMC.
This advice may change as the situation develops. The FPM urges all our members to consider how they might best support the national and international effort to combat COVID-19. If members feel they need further guidance, advice and support, please contact us.
Prof Tim Higenbottam
Dr Marcia Philbin
Chief Executive, FPM