REGULATORY FRAMEWORK ENSURES SAFETY
Parallel imports are original European supply sourced in another country of the EU/EEA and totally adapted to the destination market. Safety of the medicines is 100% ensured, as parallel traders are subject to the same regulatory requirements as manufacturers of the branded or generic pharmaceuticals, and they have to undergo regular inspections by the competent authorities.
Parallel distributors must have an EU/EEA wholesale distributor license and apply internal supply controls. This includes product verification, supplier verification and audit. For a company to get the license, it has to meet the requirements set in the EU Good Distribution Practice (GMP) guidelines in accordance with Article 84 of the Directive 2001/83/EC, that ensure that the quality and integrity of medicines is preserved in the supply chain. For those companies that also do repackaging, compliance with Good Manufacturing Practice (GMP) guidelines is also required.
With the introduction of the Falsified Medicines Directive (FMD), parallel imported products must carry both unique Identifiers (2D barcodes) and anti-tampering devices like all other medicines. Affordable Medicines Europe works together with regulators and stakeholders in the implementation of the Falsified Medicines Directive, rolling out this advanced end-to-end verification system to ensure that only safe medicines are sold within Europe.
In this regard, Affordable Medicines Europe is one of the five founding members of the European Medicines Verification Organisation (EMVO), alongside with representatives of the industry, the wholesalers and the pharmacists (EFPIA, GIRP, Medicines for Europe, PGEU), whose mission is to secure the legal supply from falsified medicines.
INDUSTRY INITIATIVES FOR FURTHER SAFETY ASSURANCE
In addition to these requirements, members of Affordable Medicines Europe must follow a strict and long-standing Code of Operational conduct and good practice guidelines for parallel distribution. The association also runs its own Audit Scheme, in which members, on a voluntary basis, have to comply with further requirements aimed at ensuring best practice in parallel distribution.
Falsified and Counterfeit Medicines
Affordable Medicines Europe is committed to halt the entry of counterfeit or falsified pharmaceutical products into the European market. The products imported by parallel traders must have marketing authorisation from authorised EU wholesalers or manufacturers in other EEA countries. The possible destinations of the medicines are authorised wholesalers, registered pharmacies or other persons entitled to sell pharmaceutical products to the general public.
Not only Affordable Medicines Members are dedicated to preserve the safety in the supply chain by blocking the entry of falsified medicines; but, frequently, they are also the ones who identify them and alert the authorities when they circulate in Europe. Because of their vast re-packaging and re-labelling experience, parallel traders are very often able to eliminate suspicious packages before they are put in the market and potentially harm the patients. The difference between the original package and the falsified one is normally very subtle, but parallel importers have experts who meticulously compare the packs with the original information provided by the marketing authorisation holder and report any possibility of counterfeit.
What is parallel trade?
In the Single Market parallel traders can buy pharmaceuticals in any EU/EEA country, repackage them to comply with national legislation and linguistic needs, and sell them at a lower price than the standard local price, in competition with that same identical product sold by the manufacturer or its local licensee. This is possible because prices of individual drugs vary between Member States.
The objective of parallel trade is to offer Europeans original supply of medicines at a lower price. This creates sizable savings for public health insurance systems, pharmacies and, ultimately, patients. The savings stem from the price differences of manufacturers’ prices for the same medicine between countries of the EEA. There are direct and indirect savings.
Although parallel trade is wrongfully blamed for provoking shortages or deteriorating the supply of medicines in European countries, there is little evidence to back these accusations. On the contrary, parallel trade has the ability to mitigate shortages by bringing medicinal products that are suffering from problems of supply in one country from another market in which there is a surplus.