by João Fidalgo Jorge, Lawyer and Collaborating Member of CEDU
In 2003, the European Court of Justice declared that a comprehensive ban on the mail-order sales of freely available pharmaceuticals was contrary to European Law (Case C-322/01, 11 December 2003 – the so called “Doc Morris decision”). In reaction to this decision, the German parliament went beyond the court’s ruling, and the Statutory Health Insurance Modernization Act 2004 (“GKV-Modernisierungsgesetz vom 01.01.2004”) opened the door to mail-order and online sales of prescription drugs as well. Some 10 years later, the Research Project on Internet Commerce and Pharmaceutical Crime (ALPhA – http://www.alpha.uni-osnabrueck.de) was born in Osnabrück, under the coordination of Prof. Dr. Arndt Sinn: part of the research programme of the German Federal Ministry for Education and Research (BMBF) on public safety, this joint project is funded by the “Public Safety and White-Collar Crime” branch of the programme. The project builds on the ministry’s stated aim of using the results of the research programme to preserve and increase public safety in the face of increasing white-collar crime without compromising the principles of the rule of law.
In Portugal, the Doc Morris decision effects generated some legal and policy discussions on the subject. This reaction ultimately led to new legislation which provides that retail pharmacies (and similar sales points) may now provide the remote selling of medicines, through their websites – even to consumers currently living in other member states of the European Union, under the conditions laid down on Article 9-A of the Decreto-Lei nº 307/2007 (from 31/08). The use of an electronic website depends on prior notification to the National Institute of Pharmacy and Pharmaceuticals (INFARMED), which created and is responsible for the management of an official list of all licensed Internet pharmacies. The INFARMED then monitors the Internet presence of pharmacies engaged in remote selling, in collaboration with the pharmacies themselves and also other entities (such as the criminal police), according to Articles 9-A and 45 of the mentioned DL 307/2007 – as well as the rules established by the Portaria nº 1427/2007, from 02/11.
Notwithstanding the possibility of selling pharmaceuticals through the electronic web page of each pharmacy, Article 9, nº 1, of the above mentioned DL 307/2007 says that the dispensing and delivery of medications to the public can only be carried out by the pharmacy staff referred to in Articles 23 and 24, at the pharmacy premises or at the user’s home. In other words, home delivery of pharmaceuticals should be done under the supervision of a pharmacist – or a pharmacy technician when there are only non-prescription pharmaceuticals being dispensed. However, the regime established under DL 307/2007 does not describe either the recommended conduct of the pharmacist, nor the consumer’s guarantees, since it does not clarify what exactly this supervision is. Nowadays, with prescription-only pharmaceuticals, professionals doing home delivery of drugs must have the adequate qualifications and training for it and always require the presentation of the medical prescription; but with non-prescription medicines, the dispensing of drugs up to a pharmacist or a pharmacy technician must be done in compliance with the transport rules guided by the good drug distribution practices only. These drugs should be carried throughout its circuit so that their identification remains, they do not contaminate or are not contaminated by other products or materials and that special precautions are taken against spillage, breakage or theft. Nevertheless, upon delivery of the drugs, those professionals are always required to provide all necessary information for proper use of the pharmaceuticals. According to proponents of e-commerce, pharmaceutical advice could also be provided via email or phone, although they are aware that, in this case, the decision of receiving (or not receiving) such orientation depends solely on the consumer.
But one thing is selling and what about the buyers’ perspective? After all, buying medicines from the Internet may well be a risky operation. For instance, there is no (official) list of countries from which it is considered safe for consumers to order from Internet pharmacies, although some important steps were taken when the Portuguese legal system implemented Articles 31 and 32 of the EU Cybercrime Convention on cross-border cooperation and access to data stored on computers. Also, it is not a criminal offence, in the Portuguese jurisdiction, for pharmacies to sell pharmaceuticals over the Internet without license to do so, since this conduct is merely subject to other, non-criminal fines.
Some still say it is very difficult to prove the requirements of danger (more than damage), in order to prosecute a crime that falls under the provisions of pharmaceutical crime. Add that to the fact that the legislation is not clear enough on the subject and there might be some hurdles to the prosecution of pharmaceutical crimes. The investigation itself shall not offer great hurdles – at least not more than any other crime investigation – unless the crime was committed abroad or through the Internet.
Although already established, the Portuguese Cybercrime Law offers new challenges to an old system, defying its chances within the constitutional obstacles – mainly related to private data protection. Perhaps the greatest obstacle remains the (fairly) low legal culture on pharmaceutical crime, despite the progress that the sector has seen in recent years.
The final results of the comparative-law investigation made by the ALPhA project collaborators – from all 28 EU Member States – will be presented at a conference held in Osnabrück, Germany, on the 21-22 June.
Picture credits: Ecommerce, logistics by Tech in Asia.