How to Set Up a Distance Selling Pharmacy
Rushport has helped more clients secure permission to open distance selling pharmacies than any other advisor. In fact, we have secured more NHS permissions for distance selling pharmacies than every other consultant, advisor and law firm in the UK all added together.
Pharmacists often use the terms "private pharmacy", "NHS pharmacy" and "distance selling pharmacy". Some pharmacists contact us to say that their pharmacy will be online so they "don't need physical premises", which is wrong. Before starting out on the path of opening any of these it is important to make sure that you know what you really mean.
All pharmacies in England are regulated by the General Pharmaceutical Council ("GPhC"). By registering your premises with the GPhC and filling out the registration of new premises forms and passing your GPhC inspection you have a pharmacy that most people would refer to as a "private pharmacy" even though there is nothing particularly private about it. That private pharmacy can operate from normal retail premises or could operate purely online and be a distance selling pharmacy (even though it still needs GPhC registered premises to operate from).
Then you have to ask if you want to provide NHS services from your pharmacy. If you do then you need to make an application to the NHS for permission to be on the relevant NHS "pharmaceutical list". This section is about that application process and what we can do to help you secure permission from the NHS to provide NHS services.
The NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 contain an exemption that allows pharmacists to open an NHS 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 NHS Resolution (formerly known as the NHS Litigation Authority). This is because NHS England or NHS Resolution 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. We receive lots of enquiries about how to set up an internet pharmacy and we hope that this page, along with our information pack (available on request) will answer most of your questions.
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 a 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 SOPs for distance selling pharmacy applications and we can tailor these SOP's to meet the individual operating requirements that each pharmacy company has. 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.
Since 2016 we have handled over 50% of all distance selling applications that have gone to appeal and our success rate is 100% where applicants instructed us from the beginning of the process
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.
1. 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.
2. Will I need Planning Permission?
Some types of premises will come with suitable planning permission, e.g. retail units. For others you will need to check with a landlord to find out what type of planning permission the proposed premises operates under 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 distance selling 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, however from 1 September 2020 the use classes have been changed with three new use classes covering shops, financial and professional services, restaurants and cafes, offices, learning and community uses. This change should make it easier for premises to be deemed as suitable for use as a distance selling pharmacy. It is also possible to receive permission to operate a pharmacy from a residential address 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! In addition, the GPhC will want to see that any pharmacy at a residential address is separate and secure with its own access and therefore an outbuilding such as a converted garage or other suitable structure is the best option as a room within a residential property id likely to be refused by the GPhC.
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.
3. Does the GPhC have different standards 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. The GPhC will not be looking at whether the application should have been approved by the NHS 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 and parts of the guidance can be incorporated into SOPs. Any new contractor will need to understand the GPhC guidance as it applies to distance selling pharmacies and ensure that they can demonstrate compliance with the guidance.
For understandable reasons, the GPhC is very cautious about approving pharmacy premises at a residential dwelling and it is advisable to have a completely separate annex or garage conversion if this approach is being considered.
Remember - you can't dispense an NHS or private prescription until the premises have been registered with the GPhC.
We are happy to help and guide you through the GPhC registration process that all new pharmacies have to go through. Our services in this area range from providing templates for you to work from all the way to setting up premises and hosting GPhC inspections.
4. Do I need a website?
Until recently, the answer to this question was "no". Technically there was no website requirement. However, from 1 April 2021 all NHS distance selling pharmacies must have a website. In addition, the website needs to have particular types of information on it. There are quite a few companies provide pharmacy websites. Some of these companies provides websites for a large number of pharmacy contractors but despite the fact that they all claim to be compliant with the various regulations and guidance we have found that they are not. To fill this gap we have worked with leading pharmacy website provider pharmacymentor.com to enable them to provide a website that meets the requirements of the Regulations and also the SOPs that we provide. There is no other pharmacy website provider that provides this service, so we recommend speaking to the Pharmacy Mentor team to discuss this further - click here for more information.
Looking at the questions above, it should become clear that there are a number of different considerations and these include;
- Identifying the right premises.
- Checking with the landlord that they will allow the premises to be used as a pharmacy.
- 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.
- Making sure your application is completed properly.
- Making sure you have robust SOPs in place.
- Considering the GPhC requirements for opening in the premises you have chosen.
- Think about your website - we can help you with that too!
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.