FDA calls for drug firms to declare costs

FDA calls for drug firms to declare costs

Efficient drug price controls should be strictly enforced to reduce overpricing caused by the dominant market position enjoyed by some drug companies, which impedes public access to medicine, a seminar has been told.

Siriwat Tiptaradol, former secretary of the Food and Drug Administration (FDA), suggested the Department of Internal Trade (DIT) strictly enforce price control measures, with pharmaceutical companies told to declare details of the cost of each drug manufactured.

He was speaking at a seminar on "10 years of compulsory licence implementation and access to essential medicines" on Tuesday in Bangkok. If the cost is declared, the DIT can consider whether the selling price is reasonable, said Dr Siriwat, adding the Ministry of Public Health (MoPH) should be able to provide experts to help analyse whether a declaration of manufacturing costs of each drug is valid.

A patent for a new drug will protect an innovator's right to be the only manufacturer for 20 years. The monopoly often results in higher prices, Dr Siriwat said.

However, compulsory licensing (CL) is still necessary in some cases, he added. CL comes into play when a government legally issues a licence over expensive medicine protected by patents. CL is often used in cases of emergency. The licence will enable the country to temporarily import generic copies of drugs or manufacture the generics, according to the seminar.

Chalermsak Kittitrakul, an officer with the Aids Access Foundation, suggested a revision of the intellectual property system to make drugs more accessible.

It should be more balanced as it currently gives importance to business, rather than health and public access to medicine, he said.

Mr Chalermsak also suggested that CL should be considered regarding the hepatitis C virus medicine Sofosbuvir, which costs 2.5 million baht for a three-month dose, compared to 20,000 baht for the generic equivalent made in India.

Thailand's first CL was issued in 2006 over Efavirenz, an antiviral drug for HIV-infected patients, after more than 50,000 HIV-infected patients died because the drug's high prices put the drug out of their reach.

However, CL usually angers companies which hold patents and raises concerns about international trade. However, one study suggested CL doesn't result in many trade sanctions being imposed on governments which impose it in the long term.

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