New laws governing the reimbursement of medicines, medical devices and foodstuffs for special medical purposes have been signed by the President.

The Act will come into force once it is announced in the Official Journal but, for the most part, will not take effect until 1 January 2012.

The major changes to the initial draft are:

  • the removal of the 3% reimbursement tax
  • limitation of the pay-back mechanism, with any excess amount shared 50:50 between companies and the National Health Fund
  • due quotes to be determined by administrative decision (subject to appeal) of the Minister of Health, with no use of notarial deeds
  • sanctions for non-compliance with the ban on incentives to be imposed by regional pharmaceutical inspectors, not the Minister of Health
  • more powers for pharmaceutical inspectors to monitor and audit pharmacies; (but not physicians)
  • a reduction in wholesale margins to 7% in 2012, 6% in 2013 and then 5% from 1 January 2014 onwards

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The original publication date for this article was 27/05/2011.