Vertex Law

Legal issues for pharmacy websites: Part 2

by Nick Austen and Ben Deeble-Rogers

Nick Austen and Ben Deeble-Rogers, of Vertex Law's Pharmacy Team summarise some of the main legal requirements for pharmacy websites offering online pharmacy sales.

In the first of our two features on the legal framework governing pharmacies trading online, we discussed the regulations governing “brochure sites”, i.e. the more simple websites which, as the name suggests, simply advertise the existence of a pharmacy.  We noted that these regulations cover wide areas such as web accessibility and data protection.  In this article we consider “e-commerce sites” and some of the additional issues facing pharmacies in advertising and selling medicines online.

There are two overlapping layers of regulations to consider; first the more general obligations that are placed upon the majority of e-commerce websites (in addition to those obligations discussed in the previous article) but which are relevant to online pharmacies and second, the codes of practice that specifically regulate online pharmacies.

The Electronic Commerce (EC Directive) Regulations 2002 (the “E-Commerce Regulations”)

The E-Commerce Regulations will apply to pharmacies that sell medicines via a website and, like a number of regulations concerning brochure or e-commerce sites, the Regulations place a number of ‘information requirements’ on online pharmacies. 

In order to comply with the E-Commerce Regulations there are numerous pieces of information that should be provided in a clear, comprehensible and unambiguous manner, before any order is placed.  Below, are just some of the key pieces of information that should be displayed on the websites of all English pharmacies that sell online:

(a) the fact that the online pharmacy subscribes to a code of conduct (the Code of Conduct for Pharmacists and Pharmacy Technicians) and information on how the Code may be accessed electronically;

(b) the different technical steps that need to be followed to conclude a contract;

(c) a description of the technical means by which the customer can identify and correct input errors before he places an order; and

(d) the languages offered for the conclusion of the contract.

Once a customer has placed an order with the pharmacy the pharmacy should, without undue delay, and in order to comply with the regulations, send the customer an acknowledgement of receipt and provide the customer with an opportunity to identify and correct any input errors they may have made prior to placing the order.  Online pharmacies that fail to comply with these requirements run the risk of allowing their customers to be able to terminate the contract.

The Consumer Protection (Distance Selling) Regulations 2000 (the “Distance Selling Regulations”)

In circumstances where a consumer and a supplier do not meet face-to-face, the Distance Selling Regulations are likely to apply.  Below is just some of the information that online pharmacies will need to provide their customers with in order to comply with the Distance Selling Regulations if they are selling medicines online.  The information must be conveyed in a clear and comprehensible manner and the information must be supplied to the customer in ‘good time prior to the conclusion of the contract’.  The information includes:

(a) the identity of the online pharmacy and, if payment is required in advance, the pharmacy’s address;

(b) a notice that the customer has the right to cancel the contract without cause for seven working days following the day of delivery, other than in exceptional cases; and

(c) the geographical address of the place of business of the supplier to which the customer may address any complaints.

In circumstances where the customer has a right to cancel their order, and they choose to do so, the cost of returning the goods will be the responsibility of the online pharmacy unless it has provided in its terms and conditions that the cost of returning the goods is to be borne by the customer.

Lawyer’s tip: many website developers are actively marketing their services to pharmacists, promising differing levels of service (and cost).  When discussing their brief, question them on the various regulations mentioned in this article.  If they profess to have experience in producing pharmacy websites, they should have at least a working knowledge of the issues involved and be able to address basic compliance issues as part of the initial cost.

The Pharmacist’s Code of Ethics

The Code of Ethics for Pharmacists and Pharmacy Technicians (the “Code”) provides a number of principles that the pharmacy profession must follow.  The RPSGB has published a guidance note that expands on the Code and details many of the professional responsibilities of pharmacies that sell medicines online (the “Guidance Note”) http://www.rpsgb.org/pdfs/coepsgintpharm.pdf

The Guidance Note provides a number of mandatory professional standards that must be followed by online pharmacists.  The scope of this article does not cover all of the standards set by the Code and the RSPGB Guidance Note and only some of the key provisions are considered.  It is important to bear in mind that all of the laws and regulations that apply to pharmacies, such as the Medicines Act 1968 and the Pharmacists and Pharmacy Technicians Order 2007, will equally apply to online pharmacies.  However, the following highlights some of the main issues that are specific to online pharmacies.

Website Requirements

As you may expect, transparency is important; those providing online pharmacies must be readily identifiable.  For instance, the Guidance Note requires that the following information must be made available to all patients of an online pharmacy:

(a) the name of the person(s) or the legal entity that is the owner of the pharmacy;

(b) the pharmacy’s physical address at which the business is conducted;

(c) where applicable, the name of the superintendent pharmacist;

(d) information as to how patients can confirm the online pharmacy’s registration with the RPSGB; and

(e) details of how the patient may make a complaint about the online services provided.

The Level of Service Required from Internet Pharmacies

Patients are entitled to expect the same level of service from online pharmacies as they would receive from any traditional ‘bricks and mortar’ pharmacy.  In addition to ensuring that the same level of advice is available to online patients, online pharmacies must:
 
(a) obtain sufficient information about the patient and the condition being treated so as to be able to assess the suitability of any POM or OTC ordered;

(b) when applicable, be able to advise the patient that their circumstances dictate that it would be in their best interests to have a face-to-face consultation with a local pharmacy or appropriate healthcare professional; and

(c) identify the pharmacist who is assuming professional responsibility for the supply of medicines.

Security, Confidentiality and the Necessary Checks

Other than in some limited circumstances, POMs must only be supplied in accordance with a legally valid prescription.  Therefore, online pharmacies must set in place the necessary systems to prevent the unlawful sale and supply of POMs.

As an online pharmacy, maintaining the security and confidentiality of your patients’ information will need to be a high concern.  There are standards that online pharmacies must meet in respect of keeping their patients’ information confidential.  The RPSGB Guidance Note provides that internet pharmacies must meet the minimum standards specified by the International Organisation for Standardisation (ISO) (ISO/IEC 27001:2005: www.bsi-global.com)

Conclusion

As an overview, you will see that making the step from a brochure site to an e-commerce site requires some careful attention to be paid to the detail.  A good website developer will help you with this at the time of set-up, but you must quiz them to be sure that the product that they are selling to you is likely to be compliant, or at least set up to facilitate compliance without additional development cost.

The RPSGB internet logo can be applied to the homepage of participating websites of registered pharmacies as part of a quality assurance and in order to give consumer confidence.

We think that there will be an increasing focus on pharmacists being able to show the quality and suitability of their services being made available online, with an expectation of regulatory compliance part of that focus.

Vertex Law are pharmacy specialists, based at 23 Kings Hill Avenue, Kings Hill, Kent ME19 4UA. Visit www.vertexlaw.co.uk for information or contact Nick Austen on 01732 224018.

DISCLAIMER
The material in this article has been written for the purpose of giving a general overview of the law in this area and is not intended to be relied upon as specific advice.
 
Vertex Law LLP will not be liable for any loss or damage (whether direct, indirect, or consequential) occasioned to any person acting, or omitting to act, or refraining from acting, as a result of this article - this does not exclude or limit Vertex Law LLP’s liability for death or personal injury caused by negligence.