High fees to criticize pharmaceutical registration of new medicine

The Interfarma, an organization that brings together 56 pharmaceutical laboratories that are responsible for 82% of sales of medicines in pharmacies Brazilian reference, criticized the increase of amounts charged by the Government for registration of new drugs in the country and warned that the measure will raise the cost to entry of innovative therapies.
The increase in rates, valid from the day 9 was published on Wednesday in the "Official Journal of the Union" and, as the entity, the largest rate increase occurred in the category of reference drugs, whose tribute went from $ 80,000 to $ 234,000. "It affects just the entry of innovative treatments in the country, which still do not have similar and generic versions," said the Association.
The fees for similar medicines and generics, in turn, rose from $ 21,000 to $ 61 thousand in the first case and $ 6000 to $ 17,000 in the second. The registration of new routes of administration of the medicinal product and of new combinations of active ingredients have also been reset and went from $ 21,000 to $ 53 thousand.
As the Chief Executive of Interfarma, Antonio Britto, budgetary difficulties faced by the Government are known, but "we must reaffirm, respectfully, that the big problem is rates in low ratio between the amounts paid and the services received.
"We have recognized and applauded the slow advances of Anvisa in review of processes and reduction of time limits. We understand, we wish and we appeal to the new rates come accompanied by a firm determination in order to conclude very quickly the agenda of regulatory developments, in particular, to post-registration, transfer of ownership, time of product registration, national and international inspections, "said in a statement.
The organisation pointed out that the measure aggravates the "underfunding" folder of health, whose budget in 2015 has already suffered cuts of $ 13.4 billion, or 12%.