Market entry suspension clarified

Market entry suspension clarified

April 28, 2020

On 25th March 2020, NHS England and NHS Improvement (NHSE&I) suspended the processing and determination of market entry applications to allow staff who work on these tasks to be redeployed to functions which have higher priority during the current pandemic and to ensure contractors were protected from the need to read and respond to applications at the early stages of the outbreak. PSNC has been working with NHSE&I to clarify the suspension.

Pre-determination applications

PSNC has been informed that applications before NHSE&I has made a decision were suspended for good cause under the regulations – that good cause being the COVID-19 outbreak. If there are pressing reasons why an application should now proceed – for business or pharmacy service continuity or pressing reasons for the contractor – NHSE&I may progress that application. Applicants will have received an email from Primary Care Support England (PCSE) advising them of what they should do if they wish to ask NHSE&I to continue to progress their application.

Business or pharmacy service continuity could include consolidations, closures (for example, as part of a business merger), relocations and change of ownership applications. Pressing reasons for contractors might involve, for example, issues associated with leases and health and safety requirements (e.g. social distancing concerns). Applications for a new pharmacy to fulfil a need or fulfil an unforeseen benefit, and applications for distance selling pharmacies (DSPs) are unlikely to be given priority at this time.

Post-determination applications

The suspension of market entry activity only applies to those applications which have not yet been determined by NHSE&I. Where NHSE&I has reached a decision on the application and that decision has been notified to the applicant and interested parties, then the usual timescales apply. For the avoidance of doubt this means that:

  • Appeals against decisions must still be submitted to NHS Resolution (or the First-tier Tribunal in relation to decisions to refuse an application on fitness grounds) within 30 days;
  • Where an applicant gave a best estimate they must notify NHSE&I, via PCSE, of their premises within six months of the decision to grant an application being notified to the applicant;
  • Notices of commencement and notices of consolidation must still be submitted within six months of a decision to grant an application being notified to the applicant; and
  • NHSE&I may only extend the six month grant period by up to three months. No further extensions may be granted by NHSE&I.

Contractors are advised to check deadlines and act accordingly. NHSE&I is considering steps to assist contractors, as appropriate, and PSNC is in discussion with NHSE&I on this.

Temporary closures or relocations

Applications relating to a temporary closure or relocation due to the COVID-19 outbreak and made under paragraph 27, Schedule 4 of the regulations are not covered by this suspension and contractors should therefore submit such applications directly to the relevant NHSE&I regional team.

PSNC seeking new regulations

PSNC has also requested changes to the NHS pharmaceutical regulations as soon as practicable, to assist management of market entry cases at the current time. PSNC is keen to ensure that contractors are not disadvantaged by the suspension and any issues arising from it are resolved fairly for all – for those making applications and for those who were protected from the need to read and respond to applications at the early stages of the outbreak.

PSNC is continuing to work with NHSE&I on these issues and is drafting further information and FAQs to assist contractors.

For any queries, please contact Gordon Hockey, PSNC’s Director of Operations and Support.

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