[Ip-health] Thai FDA to require disclosure of production costs

[ben.krohmal@keionline.org]

http://www.bangkokpost.com/News/17Apr2007_news04.php

Bangkok Post
April 17, 2007

Cost of new drugs must be stated

FDA: Law will protect rights of consumers

APIRADEE TREERUTKUARKUL

Pharmaceutical firms will be required to declare the cost of each new drug
listed for introduction in the country in a bid to protect consumer
rights, Food and Drug Administration (FDA) secretary-general Siriwat
Thiptaradol said. The declaration of production costs will be stipulated
in a new drugs bill now being scrutinised by the Council of State.

The move, which is aimed at seeking a balance between the interests of
patent holders and the public, might affect sales to some level, he said.

However, he did not think it would mean a double standard for the makers
of existing drugs.

''Drugs are a special product and the FDA has a duty to ease the problems
of drugs access while protecting consumers' rights. In the meantime, we
also have to ensure the move will not severely hurt the benefits of drug
companies,'' he said.

In February, the government announced a decision to adopt compulsory
licensing for importing or producing copycat versions of costly Aids and
heart drugs Efavirenz, Kaletra and Plavix.

Abbott Laboratories, the patent holder of Kaletra, rejected the move by
withholding a plan to introduce new drugs _ including Aluvia, which is an
upgraded formulation of Kaletra _ in Thailand.

However, the company earlier this month decided to cut the Kaletra price
to 3,488 baht per month, down 40% from its previous proposal. The new
price could be cheaper than the generic version of the anti-Aids drug.

But the Public Health Ministry has yet to make a final decision on whether
to accept the company's offer or maintain its previous plan to import
generic versions of the drug.

Dr Siriwat said he believed the new law would not cause other drug firms
to withhold the introduction of new drugs in Thailand as Abbott did.

''The drug price should be affordable for people in each country, but that
is not always the case. For example, leukaemia drugs cost a patient nearly
100,000 baht a month, whereas the average monthly income of Thai people is
only 10,000 baht. As a result, some patients were almost bankrupted by the
overpriced drugs necessary for treatment,'' he said.

Apart from the issue of overpriced drugs, pharmaceutical officials will
keep a close watch on the marketing and promotional tactics of drug firms,
particularly the way they sponsor trips for health professionals to attend
seminars and conferences abroad.

Jiraporn Limpananont, an academic at Chulalongkorn University's faculty of
pharmaceutical sciences, said drug companies have invested heavily in
marketing and promotional campaigns, and that made drugs too costly.

This is unfair to consumers, she said.

''It's necessary to seek a balance between the patent holders and the
public. Live-saving drugs should not be products that only the well-to-do
can afford,'' she said.

Ms Jiraporn also questioned the proposed revision of the patent law by the
Department of Intellectual Property, which would allow opponents of
patents to contest the process only after approval is given.

Without ''pre-grant'' opposition, local drug firms would not be able to
produce generic versions of patented drugs until disputes were over, and
that would mean Thai consumers would be stripped of fair access to cheap
drugs, she said.