On 9 November 2016 the Chamber of Deputies passed a new amendment to Act No. 378/2007 Coll., on Pharmaceuticals (the “Amendment”). It stipulates that the State Institute for Drug Control (“SUKL”) will collect and analyse data from market authorisation holders, distributors and pharmacies concerning the volume of pharmaceuticals present in the Czech Market.
The Amendment is designed to put limits on the re-exportation of pharmaceuticals from the Czech Republic abroad and to ensure that there are sufficient pharmaceuticals available for patients in the Czech market.
If at any stage SUKL forms the conclusion that there is an insufficient quantity of an irreplaceable pharmaceutical (i.e. a pharmaceutical that cannot be replaced due to its therapeutic quality) to cover the needs of Czech patients, it shall notify the Czech Ministry of Healthcare (the “Ministry”).
Provided the Ministry shares the opinion of SUKL, the pharmaceutical will be placed onto a list of irreplaceable pharmaceuticals, which will be publicly available on the website of the Ministry. For all pharmaceuticals on this list, notification of SUKL will be required prior to any re-exportation abroad. If SUKL does not forbid the re-exportation within 15 working days after notification, the distributor will be permitted to re-export it.
For a breach of the above rule, a fine up to CZK 20,000,000 or a ban on business activities for up to 2 years can be imposed.
As a next step, the Amendment will need to be passed by the Senate and then signed by the President. It is expected the Senate will decide on the Amendment by 18 December 2016.