Elly Burhaini Faizal,
Source: The Jakarta Post
October 19 2012
HIV/AIDS and Hepatitis B (HBV) sufferers are expected to get wider access to quality medicines at affordable prices as local drug manufacturers now have the authorization to produce anti-retroviral medicines.
The drug manufacturers, however, will still have to pay the royalties for producing the patented drugs.
Local production of patented drugs has been made possible with the issuance of Presidential regulation (Perpres) No. 76/2012 on patented drugs on Sept. 3.
“We will ensure the availability of good-quality, safe and effective generic versions of anti-retroviral and anti-viral drugs,” said HM Subuh, infectious disease control director at the Health Ministry, in Jakarta on Wednesday.
Under the regulation, local drug manufacturers can produce and or import the generic versions of several drugs necessary for the treatment of HIV and HBV.
These are highly active anti-retroviral drugs that include Efavirenz; Abacavir; Didanosine; a combination of Lopinavir and Ritonavir; and Tenofovir, an anti-viral medicine used to treat chronic HBV.
Speaking separately, the Health Ministry’s director general for pharmaceuticals and medical equipment Maura Linda Sitanggang said local drug manufacturers would pay royalties for each and every generic version of anti-retroviral and anti-viral drugs sold as several pharmaceutical companies still owned the patents.
“Actually, we have no fixed royalty rate. But the 2012 regulation requires us to pay 0.5 percent of total sales [of the generic products] to the original pharmaceutical companies,” she said, referring to such companies as Merck, Glaxo SmithKline, Bristol Myers Squibb, Abbott and Gilead, that own the patents.
The Perpres was promulgated in 2004 and was first used to provide HIV-infected patients with first-line anti-retroviral therapy.
This year’s revision allows for the production and or importation of generic anti-retroviral products for not only first but also second-line anti-retroviral therapy.
“With the 2012 regulation, we obviously can improve access to quality but affordable drugs,” Linda told The Jakarta Post.
The implementation of this Presidential regulation is one of two mechanisms, including compulsory licensing, for drug-patent waivers allowed by the World Trade Organization’s trade-related aspects of intellectual property rights agreement.
“We’re using this mechanism concerning public interest on the production of quality but affordable medicines to treat HIV and HBV,” said Linda.
The prevalence of patients with HBV antigens in Indonesia is considered high as the 2007 Basic Health Research (Riskesdas) showed that the number of people in Indonesia infected with HBV stood at 32.8 percent.
Meanwhile, HIV/AIDS prevalence in Indonesia stands at 0.3 percent of the total population, which is quite low. However, this may increase as Health Ministry data shows that there are up to 6 million people indulging in high-risk sexual behavior.
To tackle the problem, the ministry has appointed 314 hospitals in regencies and municipalities as anti-retroviral therapy referral hospitals, with about 70 percent of regencies and municipalities in the country already having access to the therapy.