Welcome to the website of BAPIE, the Belgian Association of Parallel Importers and Exporters.
One of the goals of BAPIE is to safeguard the free movement of medicines, and to counteract any attempts to restrict the freedom of choice for the consumer through trading patterns.
You can find more information about this topic throughout our website and news section.
“Parallel trade” of products means that such trade takes place outside and – in most cases- in parallel with the distribution network that the manufacturers or original suppliers have established for their products at a Member State, while it concerns products which are in every respect similar to the ones marketed by the distribution networks.
Parallel trade benefits from price differences in different EEA countries for identical products. Therefore, parallel traders buy products at a lower price in one EEA country and then transport, repackage and resell them in markets with higher prices. Because of the different languages (leaflets, product information on the boxes, …), a parallel trader indeed needs to repack the product by relabelling blisters, inserting new leaflets and putting the products in a new box or over-label the original box.
Parallel trade is a lawful form of trade, based on the EU Free Movement of Goods Principle as repeatedly confirmed by the Court of Justice of the EU and is encouraged by the European Commission so to move towards a single internal market.
Parallel trade in medicines is good for the European economy since it provides for intra-brand competition with pharma companies; it is good for the health care systems and patients since it helps solving shortages on the market and puts pressure on the prices. Parallel exporters are registered as pharmaceutical wholesalers who supply the intra-European market. Parallel importers place medicines from another country market in their market of destination, who must in addition hold a manufacturing authorisation and comply with the relevant GDP (Good Distribution Practices) for the necessary repackaging. Parallel trade is also supervised by the European and Belgian health authorities.
Please click this link for more information in respect of parallel trade.
Through BAPIE, Belgian parallel importers and exporters unite with a view to protect and facilitate the free movement of medicines in the European Economical Area (EEA).
BAPIE is a member of “Affordable Medicines Europe“, which is the only Brussels-based non-profit organisation which brings together the licensed European pharmaceutical parallel distribution industry, championing the industry’s achievements and the benefits of its products.
Parallel trade in medicinal products stems from price differentials between different national markets within the European Economic Area (EEA). Parallel traders buy products marketed by the original manufacturer at a lower price in one country and sell them at a higher price in another country. The basic principle of free movement of goods within the EU and EEA creates an opportunity for parallel trade in medicines. Once a product is legally placed on the market in a country within the EEA by the owner of its trademark rights the owner cannot rely on these rights to prevent the further sale of the product within the EEA. Parallel trade is likely to exist wherever there are price differentials. Various estimates by independent economic consultants on the share of the pharmaceutical market in the EU taken by parallel-traded products put it at 2–3%. Parallel trade in general is based on the principle of free movement of goods and has contributed to the development of the Internal Market to the extent that more products at different prices move from one national market to the other and are thus available to the purchaser.
Its legality has been recognized by the Court of Justice of the European Union since 1976. Parallel trade of a medicinal product is a lawful form of trade within the Internal Market based on article 34 of the Treaty on the Functioning of the European Union (TFEU) and subject to the derogations regarding the protection of human health and life and the protection of industrial and commercial property, provided by article 36 of the TFEU. The Court has ruled (Case C 44/01 delivered on April 8, 2003 paragraph 63 of the judgement) that “in completing the Internal Market as an area without internal frontiers in which free competition is to be ensured, parallel imports play an important role in preventing the compartmentation of national markets”. The European Court of Justice has repeatedly confirmed that medicinal products are not exempted from the rules of the Internal Market and has condemned State measures, which restrict, without appropriate justification, parallel imports of medicines.
With a specific authorization from the government in the country of destination for the medicine, the parallel trader can sell it to wholesalers or direct to pharmacies. The parallel trader must bear costs associated with regulatory compliance, purchasing, transport, warehousing, insurance, repackaging, quality assurance, distribution and promotion. All medicines – including parallel traded ones – are strictly regulated by either national health authorities in Belgium : AFMPS/FAGG or by the European Medicines Agency. Parallel traded products need marketing authorizations, and parallel traders must possess manufacturing authorizations if they make changes to the label or outer package demanded by local law. Parallel traders need wholesale dealing authorizations too.
Parallel trade is uncontrovertibly safe. Even if their supplies cross EEA internal borders (which manufacturers often consider a ‘complex’ supply route), the supply chain of parallel trade is resilient in terms of quality assurance as well as against the entry of falsified products into the legal supply chain. Several business routines make up this result:
- Parallel traders are subject to the same regulatory requirements as manufacturers of branded or generic products and undergo regular controls by the competent national and European regulatory authorities.
- Parallel traders do not manufacture any medicines themselves, nor open the primary packaging (unless in some cases, e.g. if the primary packaging is a tablet container, in which case repackaging is carried out in such conditions that the inner product is not affected).
- Parallel traders buy finished medicinal products from exporters who are well-established and authorized pharmaceutical wholesalers.
- Parallel traders do not deal directly with the consumers either, rather the parallel trader’s customer is another licensed wholesaler, a registered pharmacy or a dispensing doctor.
- All transactions are conducted through officially authorized and controlled trade channels.
- A wholesale business or a pharmacist simply has one more source to purchase medicines from, which enhances the robustness of the medicines supply chain when manufacturers try to curtail supplies.
- Parallel traders can perform product recalls as quickly and effectively as any other participant in the medicines supply chain.
- Exporters and importers both apply internal supply chain controls including product verification and supplier verification and audit, and must meet stringent external regulatory checks to guarantee patient safety.
- Parallel traders take pride in being reliable, responsible and professional business partners for wholesalers and pharmacists in community and hospital practice. In particular, BAPIE members follow a strict and long-standing Code of Operational Conduct and good practice guidelines for parallel distribution to which all members have subscribed. The BAPIE and Afforable Medicines Europe (European organization of the companies importing and exporting medications in Europe) is dedicated to ensuring the European supply chain remains free of counterfeit medicines and is actively engaged in the on-going debate. Pharmaceutical inspectors have several times highlighted the ability of parallel traders in their repackaging operations to identify and eliminate suspicious packages before they reach patients – an effective line of defense in the fight against falsified medicines. Afforable Medicines Europe (and BAPIE and its national Belgian affiliates) are active in the implementation of the Falsified Medicine Directive; Afforable Medicines Europe is one of the 5 founding members of the EMVO (European Medicines Verification Organization). Similarly, BAPIE is one of the founding members of the BeMVO (Medicine Verification Organization for Belgium) and of the LMVO (for Luxembourg).
There is no evidence that parallel trade has a negative impact on R&D in Europe. The costs of all parallel imported products are paid to the manufacturer at the price requested in the source market pricing principles allow for the recouping of R&D costs, hence every market pays for R&D. Parallel trade represents only a very small part of the total European pharmaceutical market, accounting for only around 3-4% of total sales. Whilst innovation in the pharmaceutical industry is vital for the development of new medicines, R&D represents only around 15% of the budget of most pharmaceutical manufacturers. Manufacturers have higher expenditure in other areas, such as sales and marketing, where they spend almost twice as much as they spend on R&D.