[e-drug] Generic drug debate intensifies

E-DRUG: Generic drug debate intensifies
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Compulsory licensing gives the poor access to medicines,
but at risk of trade sanctions

The Nation, March 6, 2008

Ethicists and economists fear Thailand will be taking
a major step back for social welfare if the Samak
Sundaravej government goes ahead with plans to deny
affordable cancer drugs to needy patients.

For several weeks, economic arguments have been put
forward claiming that the country would face serious
trade sanctions if the compulsory licences to import
generic cancer drugs, granted by the previous
government, are not rescinded.

"The Thai private sector is afraid of losing tariff
privileges if the US decides to impose trade
retaliation," said Thai Chamber of Commerce chairman
Pramon Sutivong, adding that 20 per cent of Thai
exports to the US, worth about US$4 billion (Bt131.5
billion), are under the United States' low-tariff
generalised system of preferences programme.

The government committee looking into compulsory
licensing said Thailand would save up to Bt8 billion
using these drugs to treat an expected 62,000 cancer
patients over the next five years.

Compulsory licensing allows the government to bypass
the patent of three breast and lung cancer drugs -
Docetaxel, produced by SanofiAventis; Erlotinib,
manufactured by Roche; and Letrozole, made by
Novartis.

Using these numbers alone, the government's choice
seems clear as the potential economic losses seem
greater than the money saved by purchasing generic
drugs, said leading philosophy scholar Suwanna
Satha-Anand from Chulalongkorn University. But when
deciding life-saving issues, there are other factors
that deserve consideration, she said.

"In fact this is a classic [philosophical] debate,"
Suwanna said. "In the utilitarian world, the minority
has to sacrifice. But human life and dignity are
unquantifiable elements that command a greater level
of respect than being measured by a baht lost or
gained here or there.

"In our real life, there are also spaces for special
relationship. For example, we won't give up our
parents' lives even if doing so would benefit millions
of other lives on earth."

Thammasat University economist Sarinee Achavanuntakul
agreed that the government cannot measure the value of
human life by numbers.

"Drugs are no ordinary commodities; they are
life-saving necessities. This is precisely the reason
the WTO established the compulsory licensing clause
for pharmaceuticals - so that needy patients could
gain access to potentially life-saving drugs, that
they otherwise could never afford," Sarinee said.

The World Health Organisation said in a report last
month that Thailand's compulsory licences are a
valuable tool that allow access to critical drug
treatments in the public health system.

Imatinib costs Bt900 per tablet, while the price of
the generic version is between Bt50 and Bt70.
Docetaxel costs Bt26,500 per 89 milligram injection,
but the generic version costs Bt4,000. Erlotinib costs
between Bt2,800 and Bt3,000 per tablet, but the
generic version is priced between Bt275 and Bt735.
Letrozole costs Bt230 per tablet, while the generic
pill is priced between Bt7 and Bt10.

"These important drugs are the results of decades of
research and development invested by pharmaceutical
companies. It is unfair to put forward the price
comparison between the original drugs and their nearly
costless copy versions," said Teera Chakajnarodom,
general manager of the Pharmaceutical Research and
Manufacturers' Association of Thailand.

"The cost of each original tablet reflects the amount
of money and research that went into inventing it, so
that companies and scientists have incentive to create
new drugs for complicated diseases," he said.

Such logic, Sarinee said, assumes patients would pay
the higher price.

"These patients can't afford the drugs at all at these
rates, so they do not constitute a market," Sarinee
said. "Therefore the companies are not really losing
any money by offering it to them at reduced rates, as
the only cost is manufacturing, which is minimal."

While not ignoring the research and development
claims, Suwanna said the pharmaceutical industry has
been the beneficiary of medical knowledge and wisdom
passed down and disseminated free of charge.

"In the capitalism-dominated world, people talk about
intellectual property without seeing the complex roots
of those ideas," Suwanna said. "The value of nature
and culture are not reflected in the costs."

Many oncologists are hopeful that the current policies
will be allowed to stand.

"Ethically and professionally, every patient deserves
the best treatment, and I'm happy if we can offer that
without concerns over their ability to pay," Dr
Suppakorn Rojananin, head of Siriraj Hospital's
surgical department, said.
.............
Bayer lashes out against compulsory licences

Bangkok Post, Thursday March 06, 2008

Nareerat Wiriyapong

SINGAPORE : Compulsory licensing (CL) is just a
short-tern solution and Thailand should come up with
better options to fix the problem of pricing drugs for
local patients, say executives of Germany-based Bayer
Schering Pharma (BSP) AG.

CLs are short-term and do not really solve the problem
itself, said Chris Lee, who heads BSP's $1.2-billion
business in the Asia-Pacific region.

"Our key message is the same as the industry's, in
that we recommend the Thai government have the
participation of all stakeholders ... not only drug
companies but others like patient groups before making
the decision," he said.

"CLs (imposed in Thailand) are a decision made by the
government only," said Mr Lee.

Former public health minister Mongkol Na Songkhla, who
was installed by the army after September 2006 coup,
imposed CLs on two Aids drug and a heart medication.

Thai health authorities earlier this year announced
CLs on three cancer drugs.

Mr Lee said CLs did not help improve Thailand's
reputation in the eyes of international pharmaceutical
companies, making the Thai market more challenging.

Non-governmental organisations contend that CLs are a
legitimate method of ensuring inexpensive medicines
for the poor. Mr Lee said that CLs limited drug
companies' profits and hindered research and
development.

However, he said CLs would not affect Bayer's plan to
introduce new drugs in the Thai market. In the next
few months it intends to launch YAZ, the first oral
contraceptive for treatment of symptoms associated
with the menstrual cycle, which was recently
registered for the Thai market.

In 2009, Bayer aims to market Nexavar, an oral therapy
for advanced kidney and liver cancers, in Thailand. It
also aims to launch rivaroxaban, an oral drug designed
to prevent and treat blood clots the year after, Mr
Lee said.

BSP was formed a year ago after Bayer AG acquired
German rival Schering's pharmaceutical business in
2006. The deal allowed BSP Asia-Pacific to increase
its revenue by 26% last year, outpacing the industry's
overall growth of 12%, he added.

Apart from China, the key growth engine that
contributed to 35% of BSP's sales in the whole region
in 2007, Mr Lee said Thailand was one of Bayer's
biggest markets in Southeast Asia.

The business of BSP in Thailand focuses on three main
areas - primary care or clinical diseases, women's
health care, and oncology or cancer treatment. BSP's
other three core businesses in the region are
specialised therapeutics, diagnostic imaging and
cardiology/haematology.

Mr Lee said BSP aimed to maintain its double-digit
growth in Asia-Pacific in the next few years. It hopes
to beat rivals to become the biggest pharmaceutical
firm in China this year.

Kannikar KIJTIWATCHAKUL (Kar)
Access to Essential Medicine Campaigner
MSF Belgium - Thailand Mission,
522 Mooban Nakorn Thai 14,
Ladphrao Soi 101/1,
Bangkapi, Bangkok 10240
Tel (+66) 2370 3087
Fax (+66) 2731 1432
Mobile (+66) 85-070-8954