Purchasing of pharmaceuticals through on-line pharmacies is on the rise and gives rise to many potential problems. Crucially the most important issue is whether the medicinal product is genuine, contains the correct ingredients, and is an approved product in the relevant regulatory jurisdiction. Medicines supplied via on-line links can come from anywhere in the world, and this method of distribution is more open to fraudulent activity.
In Europe, the European Parliament passed Directive 2011/62/EU, which relates to medicinal products for human use, and is in regard to the prevention of the entry into the legal supply chain of falsified medicinal products. The European Commission ("EC") has put some thought into how on-line pharmaceutical purchases can be made safe and to comply with the Directive. To that end, they have released a Concept Paper for public consultation on the introduction of a "common logo" for websites of legally-operating
on-line pharmacies/retailers.
The requirements are that the logo is recognizable throughout the EU and identifies the Member State in which the on-line pharmacy/retailer is established. There is also an obligation for each Member State to set up a dedicated website providing a national list of all legally-operating on-line pharmacies/retailers. The entries in these lists must have a hyperlink to the respective on-line pharmacies/retailer's website and a reciprocal link from the logo on the on-line pharmacies/retailer's website back to the national list. The point being that a customer can go to either the national list to find approvable pharmacies and vice versa to the on-line pharmacies/retailer's website and link back to the national list via the logo thus assuring authenticity.
The idea is to ensure by means of encryption a secure transit of information between the common logo on the website of an on-line pharmacy/retailer and the national list of legally-operating on-line pharmacies/retailers. In addition there will be a need to inform the general public that on-line pharmacies/retailers showing the logo on their website and where the logo does not have a successful link back to the national list, should not to be trusted.
The consultation document has proposed two options for such a logo but is open to suggestions. Any proposals submitted for the common logo must be recognizable throughout the European Union, and must enable the identification of the Member State where the online pharmacy/retailer is established (e.g., include the national flag of the Member State). In addition, within the logo there must be something to tell the potential customer that they need to verify the logo is genuine (e.g., "click to check this website"). The Commission points out that there will be no financial commitments for the use of the design of the common logo should you submit an alternative design.
Providing the encryption methodology is robust and remains secure, this would seem to be a practical method to avoid falsified medicines entering into the legal supply chain and should be helpful to those on-line pharmacies/retailers who join in the scheme. Whether this will also enhance/assist these companies in any international sales (i.e., outside the EU) remains to be seen.
Any comments on the Concept Paper whether with regard to logo design, verification technology, text, or other issues need to be made by January 17, 2013.
