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Who can open a Pharmacy

A pharmacy can be opened by anybody, anywhere in the country. However, if someone wishes to provide NHS pharmaceutical services to the public, they can only do so with the permission of the relevant NHS Board and must therefore apply to that Board to join the Boards Pharmaceutical List.

An application for inclusion in the Board’s Pharmaceutical List, is an application to provide NHS pharmaceutical services from identified premises in the relevant Board’s area.

Applications to open a pharmacy to provide NHS pharmaceutical services can be made by any individual, partnership, or company, subject to the conditions specified in the Medicines Act.

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Consultation Analysis Report (CAR)

If you take part in the public consultation exercise your response will be included in the Consultation Analysis Report (CAR), which is shared with all parties in the application process.

The Consultation Analysis Report (CAR) is a factual statement on how the public consultation was conducted, the questions that were asked and a summary of the responses received. The report also contains the numbers of replies received, the level of support and is jointly produced and agreed by the Health Board (HB) and the applicant.

It is at this point that the applicant will decide either to make a formal application for a new pharmacy or not to move forward with an application. For those that do not move forward, the process is finished.

For those who do move forward to a formal application, the HB’s Pharmacy Practices Committee (PPC) hears the new pharmacy application and takes into consideration the CAR when making their decision. How they used the CAR in their decision is explained within the record of the PPC meeting.

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New Application Information

The Pharmacy Practice Committee (PPC) is a Committee of the Health Board, with delegated responsibility for considering applications received to join the Board’s Pharmaceutical List. The Committee is constituted under Schedule 4 of the General Pharmaceutical Services (Scotland) Regulations 2009 as amended.

The PPC consists of seven members:

• Chair (non-Executive member of the HB)
• 3 lay members (nominated by the HB)
• 1 non contractor pharmacist member (nominated by the Area Pharmaceutical Committee)
• 2 Contractor pharmaceutical members (nominated by the Area Pharmaceutical Committee)

Paragraph 2 of Schedule 4 gives provisions on who can be members. Lay Members cannot be, nor previously have been a doctor, dentist, ophthalmic optician or a pharmacist, or an employee of a person who is a doctor, dentist, ophthalmic optician, or pharmacist.

The PPC holds an oral hearing to consider an application. The applicant, other pharmacies, committees, and the nominated community representative are invited to attend the hearing, but only if they have made written comments following notification of the application.

Invites are sent out a few weeks in advance and the applicant, other pharmacies, committees, and the nominated community representative can speak to the PPC and put forward their case.

The, regulations require the PPC to apply what is known as ‘the legal test’ to decide whether granting the application would be “necessary or desirable in order to secure adequate provision of pharmaceutical services in the neighbourhood in which the premises are located by persons whose names are included in the pharmaceutical list”.

Normally the PPC holds an oral hearing to consider an application. The applicant, other pharmacies, committees, and the nominated community representative are invited to attend the hearing, but only if they have made written comments following notification of the application.

Before the PPC can apply this test, they must consider a range of issues including (but not restricted to):

• What are the boundaries of the neighbourhood (i.e. the local area) surrounding the proposed pharmacy?
• What pharmacy services are currently provided to/within that neighbourhood by existing community pharmacies?
• The content of the HB’s Pharmaceutical Care Services plan
• The content of the Consultation Analysis Report (CAR)
• Comments received from pharmacies, committees, and the nominated community representative following notification of the application
• The long-term sustainability of the proposed pharmacy

The answers to these questions will allow the PPC to decide:

• Whether the current provision of pharmacy services to/within the neighbourhood is adequate
• If the current provision is not adequate, whether it is necessary to grant the application to secure an adequate pharmacy service within the neighbourhood
• If the current provision is not adequate, whether it is desirable to grant the application to secure an adequate pharmacy service within the neighbourhood

The PPC is an expert panel and uses information heard at the hearing and provided within their papers to make their decision.

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Decision of the Pharmacy Practices Committee (PPC)

The decision of the PPC and the reasons for its decision are notified to the Health Board no later than 10 working days after that decision being made. The Board then has 5 working days to inform the Applicant and those making representations of the decision of the Committee and the reasons for its decision.

The Applicant and those making representation are also notified of their right of appeal against the decision of the Committee which must be received within 21 working days of the notification being sent. Any appeals, received by the Health Board, against the decision of the Committee, are sent by the Health Board to the Chair of the National Appeal Panel (NAP).

Once the PPC make their decision they make a report for the Health Board that is sent within 10 working days of the hearing. The decision is sent to all those who attended the hearing and is also published on the HB’s public website within five working days of the Board receiving the PPCs report.

The PPC’s decision can be appealed by either the applicant or any other invited hearing attendee within 21 days from the date the decision is sent out by the HB.

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National Appeal Panel (NAP)

The role of the NAP is to consider appeals against decisions made by Pharmacy Practice Committees (PPCs) submitted by those deemed as eligible under regulations to submit an appeal.

Decisions taken by the NAP are final, but subject to possible Judicial Review.

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Role of Lay Members

The Lay Members of the PPC bring with them local knowledge and a service user’s perspective. They apply these skills to the decision-making process of the Committee ensuring the “voice of the public” is represented.

By balancing the views of the pharmacy members of the Committee and as voting members of the Committee they ensure transparency of decision-making. Their contribution to the debate and process ensures the decisions taken by the Committee are firmly rooted in the best interests of the persons whom the Board serves i.e. the patients.

PPC Members are appointed for a term of office of three years, with an option for extension for a second three years.

On acceptance of appointment, the opportunity is given to attend a training session, which will provide comprehensive information around the practical workings of the Committee, along with the chance to meet key personnel associated with the Committee. PPC hearings are quasi-judicial, and The Legal Test is applied. New members will not be asked to sit on a hearing until they have received adequate training and are fully comfortable with the processes and the procedures.