Regulatory Environment
Prohibition
Possible Constitutional Challenge
Online Pharmacies Established Outside of Ireland
The Future
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 which 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', or PSS); and
- substances which are exempt from the PSS requirement, such as certain painkillers, vitamins and mineral supplements. These products may be supplied in non-pharmacy outlets such as supermarkets.
Online pharmacies are prevented from operating in Ireland on two fronts. First, 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 online presence, with a virtual rather than fixed place of business, is nonetheless an establishment open to the public, notwithstanding the fact that it is accessed online 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 online shop is an establishment open to the public. This issue has not been tested in the Irish courts, perhaps because there is a further and more serious obstacle in the way of establishment of an online pharmacy: Regulation 13 of the Medicinal Products (Prescription and Control of Supply) Regulations 1996.
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 effectively prohibits all mail order and email 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 outlet.
The far-reaching effects of Regulation 13 operate so as to prevent an online pharmacy from operating even under the supervision and control of an existing pharmacy - Regulation 13(2) provides:
"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 not only is it an offence for a pharmacist to operate premises which receive email orders, but it is also an offence for any other pharmacy to fill an order initially received by email and passed on to that pharmacy.
Regulation 13 was enacted to prevent medicinal products from falling into the wrong hands and being dispensed without adequate control and supervision. However, a combination of email ordering together with on-the-ground supervision by the order-filling pharmacy would arguably avert this danger.
Possible Constitutional Challenge
It is arguable that a constitutional challenge could be made to Regulation 13 on the basis that it is an unconstitutional interference with an individual's right to earn a livelihood. This may be difficult to argue: a litigant would need to 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 online pharmacy which passes on a prescription to an established 'physical' pharmacy in which the customer could collect the finished product would neutralize the danger sought to be protected by Regulation 13.
The EU angle
It could also be argued that Regulation 13 is inconsistent with certain provisions of EU law, principally those dealing with the right of establishment and the free movement of services, as follows:
- 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 EC Treaty deals with the right of establishment and states that "restrictions on the freedom of establishment of nationals of one member state in another member state shall be prohibited"; and
- Article 49 of the EC 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 taken across the European Union, although none of merit has yet dealt with the issue of the e-pharmacy.
It would appear that in order to invoke Article 28 successfully to strike down Regulation 13, an e-trader would need to 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 online pharmacy from trading in Ireland, even though it may be trading in other EU member states.
Online Pharmacies Established Outside of Ireland
As Irish law currently stands, online 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, 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 online), and the user is accessing the site from a computer located in the Netherlands.
Without an amendment to the regulatory framework which places an absolute ban on online pharmacies, Ireland could lose its name as a progressive, pioneering e-commerce environment if, as anticipated, the sale of online pharmaceuticals becomes more widespread throughout Europe in the same manner as it has in the United States. A challenge to the Irish courts or the European Court of Justice could potentially resolve the issue and open up a path for the online trade of medicinal products in Ireland.
For further information on this topic please contact David Sanfey at A & L Goodbody by telephone (+353 1 649 2000) or by fax (+353 1 649 2649) or by email ([email protected]). The A & L Goodbody website can be accessed at www.algoodbody.ie.