When 10 additional member states joined the EU in 2004, the Pharma Industry successfully pressed for and obtained the insertion of a “specific mechanism” in the Accession Treaty governing the entry of the new members states into the EU, concerning medicines exports from the newly acceded states.
The prime reasons for the Pharma industry to seek the specific mechanism were:
* a fear that EU enlargement would result in a flood of parallel imports from new member countries (generally lower priced countries) to older member states (generally higher priced countries).
* a fear that the extent of patent protection for medicines would vary between old and new members states.
In practice, the specific mechanism means that patent protected medicines in the older member states are protected from imports from the newer member states, if it was impossible for the product owner to obtain a patent or supplementary protection certificate (SPC) for the relevant medicine in the newer member state at the time when the patent or SOC for the same product was filed for in the member state of threatened import.
The specific mechanism only applies if the medicine in question originates in one of the newer EU member states: Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia or Slovakia. When Malta and Cyprus acceded to the EU, further rules were applied to these 2 countries, but importing to older members states via these 2 countries cannot be used to “get round” the special mechanism, as it is the source country of the product (where it was originally placed on the market) that counts and NOT the latest country from which it is imported
This whole issue is quite complex and totally product and country specific. It is vital therefore that before spending time and money to licence a medicines import in the UK from a newer member state, the specific mechanism legal status of that medicine for that country of potential export is first checked out.