Ireland: Irish Regulation Of On-Line Pharmacies

Introduction

Huge growth across Europe in the biotechnology sector over the past three years appears to be set to continue. The pharmaceutical industry is one of the diverse range of industries comprised in this sector. This article summarises the two current blocks existing under Irish law to the development of one facet of the pharmaceutical industry: the on-line pharmacy. It also deals with possible grounds of challenge to the current regulatory regime, both under Irish and EU law.

A pharmacy is defined under Irish legislation as an "establishment open to the public for the compounding or dispensing of medicinal preparations". Legislation further provides that medical preparations may only be dispensed in a pharmacy where the dispensing is carried out "by or under the personal supervision of a pharmacist".

Irish legislation places medical preparations into three broad categories:

• medicines which must be prescribed and on prescription and must be supplied by pharmacies.
• medicines exempt from prescription control but which may be only supplied under the supervision of a pharmacist (referred to as pharmacist supervised sale "PSS"); and
• substances which are exempt from the PSS requirement such as certain painkillers, vitamin and mineral supplements. These products may be supplied in non-pharmacy outlets such as supermarkets.

On-line pharmacies are prevented from operating in Ireland on two fronts. The first is that in order to sell prescription or PSS medicine, a person would have to show that it has an establishment open to the public. Arguably, an on-line presence, having a cyber as opposed to a fixed place of business, is an establishment open to the public, albeit that it is accessed on-line as opposed to physically. There is much Irish case law on the meaning of "keeping open shop" / "an establishment open to the public" and with a modern interpretation of old legislation, there appears to be nothing to prevent an Irish court finding that an on-line shop is an establishment open to the public. This has not been tested in the Irish courts and perhaps this is because there is a further and more serious obstacle in the way of establishment of an on-line pharmacy: Regulation 13 of the Medicinal Products (Prescription and Control of Supply) Regulations, 1996 (the "1996 Regulations"). Regulation 13 prohibits the supply by mail order of any medicinal product. The term "supply by mail order" is defined as "any supply made, after solicitation of custom by the supplier, without the supplier and the customer being simultaneously present and using a means of communication at a distance, whether written or electronic to convey the custom solicitation and the order for supply". This is effective so as to prohibit all mail order and e-mail order supplies of medicinal products, be they prescription medicines, PSS medicines or even the third category of medicines such as pain killers which may be dispensed by all other types of retail outlets.

The far-reaching effects of Regulation 13 operate so as to prevent an on-line pharmacy operating even under the supervision and control of an existing pharmacy: Regulation 13(2) provides that "an owner or occupier of any premises shall not use or permit the use of such premises for the receipt, collection or transmission of orders or correspondence in connection with the supply by mail order of medicinal products". This means that it is not only an offence for a pharmacist to operate a premises which receives e-mail orders but it is also an offence for any other pharmacy to fill an order initially received by e-mail and passed on to that pharmacy.

The clear danger that Regulation 13 was enacted to avoid is that of medicinal products getting into the wrong hands and being dispensed without adequate control and supervision. Arguably the combination of e-mail ordering with on-the-ground supervision by the order-filling pharmacy would avoid this danger.

It is arguable that a constitutional challenge could be made to Regulation 13 on the basis that it is an unconstitutional interference with an individuals right to earn a livelihood. This may be difficult to argue: a litigant would need prove to the satisfaction of the court that Regulation 13 reaches further than is reasonably required in the interests of the common good. Perhaps the best argument that might achieve this end is that any on-line pharmacy which passes on a prescription to an established "physical" pharmacy where the customer could collect the finished product would side-step the danger sought to be protected by Regulation 13.

It could also be argued that Regulation 13 is inconsistent with certain provisions of E.U. law, principally those dealing with the right of establishment and the free movement of services:

Article 28 of the EC Treaty deals with free movement of goods and states that "quantitative restrictions on imports and all measures having equivalent effect shall be prohibited between Member States".

Article 43 of the E.C. Treaty deals with the right of establishment and states that "restrictions on the freedom of establishment of nationals of a Member State of another Member State shall be prohibited."

Article 49 of the E.C. Treaty deals with the freedom to provide services and states that "restrictions on freedom to provide services shall be prohibited in respect of nationals of Member States who are established in a State of the Community other than that of the person for whom the services are provided".

All three of these Articles have been the driving factor behind successful actions being taken across the E.U., albeit that none of merit have yet been taken in the area of the e-pharmacy.

It would appear that in order to successfully invoke Article 28 to strike down Regulation 13, a e-trader would need to do demonstrate how the denial of a right to supply medicinal products by mail order is particularly damaging to an importer into Ireland, insofar as it prevents the only effective means of promotion which is capable of securing the entry of foreign pharmacies to the Irish market. On the basis of proportionality, Regulation 13 could be struck down as it is not the least restrictive means of achieving the mandatory requirements of consumer health or public health while at the same time restricting trade in the least possible way.

Articles 43 and 49 could similarly be invoked to strike down Regulation 13 from the proportionality angle. Regulation 13 acts as a blanket ban preventing an on-line pharmacy trading in Ireland, although it may be trading in other E.U. Member States.

As Irish law currently stands, on-line pharmacies set up by entrepreneurs outside of the jurisdiction should consider having their sites blocked to all users attempting to access them from Ireland by using clear language stating that the contents of the site are directed solely at individuals from the relevant country and that the site should not be accessed by residents of Ireland. The site owners should go so far as to state that by accessing the site, that the user warrants and represents that it is a resident of, for example, the Netherlands (as a country which does not prohibit the sale of pharmaceuticals on-line) and that the user is accessing the site from a computer located in the Netherlands.

Without an amendment to the regulatory framework which currently places an absolute ban on on-line pharmacies, Ireland could lose its name as a progressive, pioneering e-commerce environment if, as anticipated, the sale of on-line pharmaceuticals becomes more widespread throughout Europe in the same manner as it already has in the U.S. A challenge to the Irish courts and / or the European Court of Justice could potentially resolve the issue and open up a path for the on-line trade of medicinal products in Ireland.