Philippines FDA proposes huge fee hike to fulfil new obligations
This article was originally published in RAJ Devices
The Philippines Food and Drug Administration (formerly the Bureau of Food And Drugs), has proposed a substantial increase in the levels of fees it charges for various services, including the regulation of pharmaceuticals and medical devices1,2.
The fee hike, the FDA says, is required in light of the new responsibilities handed down to the agency following the enactment of two new laws. The agency’s expenditure and revenue forecasts for the period 2010-14 under the current fee structure show a shortfall; to fulfil its new obligations and to achieve financial stability, the FDA says it must increase its overall income by at least 40%.
In the revised fees schedule, the largest increase has been in the category of product registration. The old fee for an initial one-year registration of a medical device, for example, was Pesos 1,500 (US$33) – under the new fee schedule, an initial three-year registration will cost Pesos 64,500 (US$1,402).
The FDA has tried to offset the increase in the registration fees by allowing the initial registration to last for three years, after which a one-year renewal will be required at a charge of Pesos 21,500.
Under the old system, companies had to apply for a renewal after one year, at a cost of Pesos 5,000; the renewal was valid for five years. The agency notes that about 50% of its income comes from registration fees, which can vary considerably depending on market conditions and regulatory changes.
Similar increases have been proposed for establishment/licensing fees of medical device distributors (importers, exporters and wholesalers) – from Pesos 4,000 to Pesos 14,000.
On 3 December, the FDA held a public consultation workshop to gather feedback from the industry on its revised fees proposals. The extra funds generated will be spent on the FDA’s programmes, activities and projects – a substantial amount will be spent on hiring staff, upgrading and procuring laboratory equipment and strengthening infrastructure.
The two laws that have expanded the agency’s remit are: The Food and Drugs Administration Act of 2009 (RA9711), which was signed into law in August and provides the agency with, among other things, new authority to order the ban, recall and withdrawal of health products with deceptive claims3; and the Universally Accessible Cheaper and Quality Medicines Act of 2008 (RA9502), which was implemented in November last year and under which the government has already taken steps to halve the prices of 21 essential medicines (the FDA is required to take action against those found violating these pricing agreements)4,5.
References
1. Philippines FDA, Notice of Public Hearing: Revised Schedule of Fees, 3 December 2009, www.bfad.gov.ph/default.cfm?vPageID=6&id=724
2. Philippines FDA, Draft Revised Schedule of Fees for Services Rendered by the Food and Drug Administration, December 2009, www.bfad.gov.ph/cfc/pdf.cfm?pdfid=1260
3. The Regulatory Affairs Journal – Devices, 2009, 17(5), 359
4. The Regulatory Affairs Journal – Pharma, 2008, 19(12), 844-845
5. The Regulatory Affairs Journal – Pharma, 2009, 20(8), 539-540