What is parallel distribution
Parallel distribution entails that a pharmaceutical company, independent of the marketing authorization holder distributes a centrally authorized medicine, from one Member State to another.
It is called "parallel" because it takes place in parallel with the distribution network that the producers have established in a certain Member State. However, these products are identical to the ones marketed by the official distribution networks.
In Europe, the parallel distribution of original medicines is based on the free movement of goods, in accordance with Articles 28 and 30 TFEU, and on the "regional exhaustion doctrine". Given these aspects, once a medicine is placed on the market of a Member State by the rightsholder, or with its consent, the latter cannot be against the export of the same medicine to another Member State.
Although, following the development of the internal market, the current terminology of "intra-Community trade", has replaced “import”, a term which has lost its relevance, for practical reasons, “import” is still being used at a European level, as we can see in the Commission’s Notice on the import of medicines for which marketing authorizations have already been granted (COM / 2003/0839 final).
Parallel distribution is possible whenever there are price differences.
The medicine distributed in parallel is competition to the identical medicine, sold by the manufacturer or by the local licensee. The resulting price difference is transferred to the patient or to the social health insurance system.
Parallel distributors are subject to the same regulatory requirements as manufacturers of branded or generic products and are subject to periodic checks by the relevant national and European regulatory authorities.
The parallel distribution of medicines offers significant savings to governments, insurance companies and patients, making original and innovative medicines available at a lower cost.