The NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 contain an exemption that allows pharmacists to open a pharmacy without having to show that the need for that pharmacy was identified within the PNA, or having to satisfy NHS England that the pharmacy would satisfy the test under Regulation 18 for unforeseen benefits.
This exemption is contained within Regulation 25 and is known as a "Distance Selling" or "Internet Pharmacy" contract. Even though this type of application is exempt from the more stringent regulatory tests, many of these applications are being refused by NHS England, or at appeal, by the NHS Litigation Authority. This is because NHS England or the NHS Litigation Authority will only grant the application if they are satisfied that the pharmacy procedures in place at the proposed pharmacy premises are likely to secure the uninterrupted provision of essential services to persons anywhere in England without face-to-face contact. In addition to this applicants must also satisfy NHS England that regulation 31 does not apply before their application will be granted.
There are occasions when applications will be granted without the applicant having to provide NHS England with a full suite of standard operating procedures (SOPs); however many applicants are now having to provide full SOPs at some stage in the application process. We provide advice at all stages of the application process but we prefer to be involved at the very beginning to make sure that applications are presented in the strongest way possible. An application costs £750 to submit so it is far better to get it right first time than waste an application fee. We are often contacted by applicants who have submitted their application and have received extensive letters of objection. In most of these cases the applicant has simply taken SOPs that were used in normal retail pharmacies and tried to change them to meet the requirements of Regulation 25 or bought a set of cheap SOPs from an online company which simply do not cover the requirements of the Regulations. Unfortunately this approach rarely works, as not only do SOP's need to be changed but a significant amount of additional information is required in order to meet the requirements of the Regulations.
Rushport has developed a full suite of SOP's for distance selling pharmacy applications and we can tailor these SOP's to meet the individual operating requirements that each pharmacy company has. Our SOPs cover 42 separate sections relating to the operation of a Distance Selling Pharmacy. We are aware of companies that try to sell SOPs online and can only advise applicants to be very careful about what they purchase as cheap does not mean good. SOPs are also just one part of the application process; they can be vital, or not required at all. It is important not to separate the SOPs from the rest of the application as all parts of the process link together in a successful application.
Approximately 20% of Distance Selling applications are granted at appeal, whereas our success rate in the past year was 100% where applicants instructed us from the beginning.
We receive a lot of enquiries from pharmacists who are considering setting up Distance Selling pharmacies and they regularly ask the same questions, so we have updated this page to provide some answers to the most frequently asked questions.
Q. What type of premises do I need?
It is possible for an application to be approved at any type of premises. Some pharmacists think that retail premises won't be accepted or that premises must be a certain distance from an existing pharmacy - this isn't true. The important thing is that Essential Services can be delivered without face to face contact with patients. We have had clients make successful applications retail premises, units on the first floor above retail premises, warehouses and even their own homes.
You must specify your premises in the application form, so deciding on premises is something that must be done at an early stage.
Q. Will I need Planning Permission?
Some types of premises will come with suitable planning permission, eg retail units. For others you will need to check with a landlord to find out what type of planning permission the proposed premises has and also check with the local council to ensure that the existing planning permission allows you to operate a Distance Selling pharmacy. You may need to submit a planning application, or request a Certificate of Lawful Development. The landlord is also likely to want to know what type of business will be operating from their premises, so you should ensure that they have also agreed to allow the premises to be used as a pharmacy.
The way that the pharmacy operates and the type of building chosen will impact on the planning requirements. There are different "use classes" for different properties. Most people are familiar with A1 (known as 'retail') consent, but there are many others. If you are setting up a large operation with lots of storage in a warehouse then you may require B8 (storage and distribution), but it is also possible to receive permission to operate a pharmacy from within your own home and there is precedent that one of our clients obtained for allowing an internet pharmacy to operate from a house. It is worth noting that the council did insist on security grilles on the windows of the house, so this might not be very appealing to you or your neighbours if your local council takes a similar approach!
Planning permission falls outside the Pharmacy Regulations, so the NHS should not make too many enquiries in to this area of the proposal, but some Area Teams still take a keen interest in this.
Q. Does the GPhC have different rules for distance selling premises?
The GPhC is primarily concerned with protecting the health, safety and wellbeing of the user of pharmaceutical services. The standards that they ask contractors to adhere to are not intended to stifle innovation, but are aimed at encouraging high standards. In recent years the GPhC allowed their role to overlap into areas such as planning permission, but they appear to have accepted that this is not their area of expertise as they struggled to deal with more complex planning cases and found it hard to explain why planning permission should be within their remit. The GPhC will not be looking at whether the application should have been approved or not and (probably!) won't mention planning permission, but they will want to satisfy themselves that the pharmacy fit-out and operation is of an acceptable standard before they will allow it to open and register the premises. There are new guidelines for Distance Selling pharmacy operators, but these should really be incorporated into SOPs. Remember - you can't dispense an NHS prescription until the premises have been registered with the GPhC.
Although there is only one set of guidance, there are different inspectors, so we have heard of different inspectors applying the rules in different ways. To some extent this is inevitable, as no two people are likely to interpret guidance the same way, but the GPhC appears to have more work to do to remove some of the larger inconsistencies in its approach.
We have seen examples of the GPhC insisting that home based internet pharmacies have a separate entrance from the main family home, but they don't always ask for this.
Looking at the questions above, it should become clear that there are a number of different considerations and these include;
1. Identifying the right premises.
2. Checking with the landlord that they will allow the premises to be used as a pharmacy.
3. Checking with the council to see if a planning application is required for the premises to be used in the manner that you want to.
4. Making sure your application is completed properly.
5. Making sure you have robust SOPs in place.
6. Considering the GPhC requirements for opening in the premises you have chosen.
If you are considering making an application for distance selling pharmacy contract, or if you have received an application and want to know if you have grounds for objecting to the application then please click here go to the contact us section of the website and send us an email.