Whilst the NHS remains "free at the point of contact", cuts in funding and the inability to obtain appointments and treatments that fit in with modern living is leading to a rise in private prescribing and pharmacy services.
We have acted for a number of online private prescribing and pharmacy service providers in the past year and it is becoming clear that this is a growth area in the healthcare market. Typically we are instructed by companies that are new to the UK healthcare market and have seen a gap in personalised healthcare where patients are willing to pay for access to prescribing and treatment that they would be unable to access via traditional NHS routes. Our clients have included online dermatology providers, men's health (typically erectile dysfunction and hair loss treatment), private GP services (with associated pharmacy) and hormone replacement providers. Some of these providers manufacture their own medicines to specific formulations.
Often the starting point of these conversations is a phone call from a potential new client where they say that they have researched online / distance selling pharmacy and heard that "it is very difficult to get permission to open an online pharmacy". What we have found is that there is a lot of confusion between the NHS requirements for a distance selling pharmacy. Anyone entering this area (and indeed all pharmacies whether NHS or private or a mix of both) needs to understand that the General Pharmaceutical Council ("GPhC") regulates all pharmacies, whereas those who also wish to provide NHS services must go through an additional process to secure that permission and also meet the NHS Terms of Service.
We come across a range of shared issues for these new entrants which typically involve considering;
- Is online prescribing suitable in this case? [our first question, but often overlooked]
- Who should prescribe?
- Who will regulate the prescribing? This differs depending on the qualifications of the prescriber.
- GP prescribing versus independent prescribers
- Can prescribing be advertised?
- What will the relationship between the prescriber and pharmacy be?
- Will the associated pharmacy have a website?
- Can the pharmacy provide unlicensed / compounded medicines / "specials"?
- What registration is required for online pharmacy websites?
- What involvement will the MHRA have?
- What Standard Operating Procedures ("SOPs") do I need?
- Who will write the SOPs?
- Will my current insurance cover this new venture?
Whilst these are common themes, every client is different.
Assuming projects progress we will inevitably end up making an application to the GPhC to register the pharmacy premises. This is another area where we are increasingly being asked to advise as the GPhC is deliberately vague about what they expect to see in an application or during a physical inspection. Some companies will have invested hundreds of thousands of pounds by the time they get to filling in the GPhC application form and a failed inspection can put plans back by many months.
One thing that any new entrant should be very cautious about saying is something that we hear all too often and is, "I don't need any advice on that because [xyz website] is doing it that way so I know it is legal". When I hear that my normal response is "Of course that is fine, but isn't that like saying that stealing a car must be legal because you know someone who steals cars?".
Partner | Rushport Advisory LLP