[Random-bits] March 8, 2007 Geneva Q&A Session on Thai White Paper

[James Packard Love]

http://www.keionline.org/index.php?=20
option=3Dcom_content&task=3Dview&id=3D31&Itemid=3D1

Knowledge Ecology International: Q&A Session on Thai White Paper =20
(Facts and Evidences on the 10 Burning Issues Related to the =20
Government Use of Patents on Three Patented Essential Drugs in Thailand)

Geneva, Switzerland
8 March 2007

Thiru Balasubramaniam

On Thursday, 8 March 2007, Knowledge Ecology International (KEI) =20
convened a briefing on the Thai White Paper entitled "Facts and =20
Evidences on the 10 Burning Issues Related to the Government Use of =20
Patents on three Patented Essential Drugs in Thailand", a 96 page =20
government document (www.moph.go.th/hot/White Paper CL-EN.pdf) =20
detailing the public policy rationale behind the Royal Thai =20
Government's actions in issuing non-voluntary licences for efavirenz =20
(Stocrin), lopinavir+ritonavir (Kaletra) and clopidogrel (Plavix).

The main discussant in this meeting was Dr. Suwit Wibulpolprasert, =20
Senior Advisor on Health Economics, Ministry of Public Health, =20
Thailand.  Twenty-two participants attended the briefing including =20
officials from Belgium, Bolivia, Brazil, China,the European =20
Commission, France, Thailand and the United Kingdom, international =20
civil servants from the World Health Organization (WHO) and the World =20=

Trade Organization, representatives from non-governmental =20
organizations including the International Centre for Trade and =20
Sustainable Development (ICTSD), Knowledge Ecology International =20
(KEI), M=E9decins san Fronti=E8res (MSF) and Third World Network (TWN), =20=

publication IP-Watch and the pharmaceutical industry.  This session =20
was chaired by KEI Geneva Representative, Thiru Balasubramaniam.

Dr. Suwit kicked-off the meeting by underscoring the importance the =20
Government of Thailand attached to providing their citizens universal =20=

access to treatment, an inalienable right enshrined by the Thai =20
National Security Act (2002).  At the heart of Thailand's actions in =20
issuing non-voluntary licences for efavirenz, lopinavir+ritonavir and =20=

clopidogrel lay the goal of providng these medicines to all Thai =20
citizens in need of thes products.  Efavirenz and lopinavir+ritonavir =20=

are anti-retrovirals and clopidogrel is an "anti-platelet drug which =20
is at least as effective as or more effective than Aspirin in =20
preventing coronory obstruction" (Thai White Paper, 2007).  Under the =20=

National Security Act of 2002, Dr. Suwit outlined that 62 million =20
Thais enjoyed universal access to drugs on Thailand's essential drug =20
list through one of three public health insurance schemes, i.e. (1) =20
the Civil Servant Medical Benefit Scheme,  (2) the Social Security =20
Scheme, and (3) the Universal Coverage Scheme (the gold card =20
scheme).  The Civil Servant Medical Benefit Scheme covers 5 million =20
civil servants,  the Social Security Scheme covers 8.5 million people =20=

and the gold card scheme covers 48.5 mission people.

Dr. Suwit noted that currently, only 2 million people in Thailand can =20=

afford to pay out of pocket for expensive medicines that are often =20
patented. He stressed that the issuance of non-voluntary licenses for =20=

Stocrin, Kaletra and Plavix for government use applied only to people =20=

covered by three government-backed health insurance schemes; prior to =20=

the compulsory licences, people on the government schemes who needed =20
access to Stocrin, Kaletra or Plavix could not access them as the =20
government could not afford to pay for these patented medicines.   =20
Thus, Dr. Suwit noted, that the compulsory licences opened up a new =20
market for these 3 drugs among a huge pool of 62 million people.  In =20
theory he noted that the compulsory licences should not affect the =20
market of 2 million people who could afford to pay out of pocket for =20
the three patented medicines.

Dr. Suwit reminded the audience that on 29 November 2006, Thailand =20
issued its first compulsory licence for efavirenz.  Prior to the =20
compulsory license, the price per tablet of efavirenz was $1.35; the =20
new price is 60 cents a tablet.  Thailand placed an order for 66,000 =20
bottles of efavirenz from the Indian company Ranbaxy.  The first =20
batch 0f 16,000 bottles arrived in late January.  According to the =20
Thai White paper, the new price (reduced by by more than half) will =20
permit the government to provide efavirenz to 20,000 more patients in =20=

Thailand living with HIV/AIDS.

After the Thai announcement of a compulsory licence for efavirenz, =20
Merck announced a global price reduction from $1.35 per pill to 72 =20
cents a pill.  Dr. Harvey Bale Jr., Director-General, International =20
Federation of Pharmaceutical Manufacturers and Associations (IFPMA) =20
cautioned however that the Merck announcement should not be perceived =20=

as a direct cause and effect of the Thai decision but as part of a =20
more gradual series of 3 price reductions offered by Merck. Dr. Suwit =20=

noted that whatever the case, since the issuance of 3  compulsory =20
licences, his phone was "ringing off the hook" due to companies =20
willing to negotiate price reductions on their products including =20
Sanofi-Aventis (which markets clopidogrel) and Abbott (which markets =20
lopinavir+ritonavir).  One company offered Thailand a "buy 1 get 9 =20
free" deal.

Eric Sayettat, Counsellor from the French Mission to the WTO, noted =20
that his country "favoured dialogue over measures such as a =20
compulsory licensing which were viewed like nucleur deterrants".  He =20
then posed the question to Dr. Suwit as to whether Thailand could =20
have achieved the same results (i.e. price reductions) without the =20
issuance of compulsory licensing.

Dr Suwit responded by saying that 2 years of prior negotations with =20
the pharmaceutical companies had failed.  After the issuance of the 3 =20=

compulsory licenses, however, offers from the industry for voluntary =20
price reductions had been pouring in non-stop.  Dr. Suwit stressed =20
that that from the Thai perspective, less than 15% of patented drugs =20
marketed in Thailand would be considered candidates for government =20
using noting that many patented drugs are "me too drugs" that do not =20
offer much therapeutic improvement over "existing low priced non-=20
patented drugs".  With respect to the issuance of further non-=20
voluntary licences, he noted that further candidates for government =20
use would have to past the muster of thejoint "Subcommittee for =20
Implementing the Government Use of Patents on Essential Patented =20
Drugs" comprising of 21 members which met strict public helath criteria.

According to Dr. Bale (IFPMA), there was a perception that there was =20
no "serious discussion between governments and the research-based =20
pharmaceutical industry" noting that second line ARVs were often =20
priced below the generic price.  Mr. Sayettat (France) further =20
reiterated that the pharmaceutical industry offers differential =20
pricing for products based on countries' respective incomes.

Dr. Suwit responded by saying that Thailand was a developing country =20
with a national health insurance scheme.  He asserted that everyone =20
in Thailand is entitled to access to essential medicines noting "we =20
have a polticial and social obligation".  He stressed that contrary =20
to popular opinion, the major impetus behind the compulsory licences =20
were not to save money in the health budget but rather to "increase =20
patient access to essential drugs".  He noted that the Thai =20
government spent 40 million baht alone for its 5 million civil servants.

Riaz Tayob from Third World Network (TWN) asked Dr. Suwit as to how =20
he perceived the effects of the compulsory licences on mortality and =20
morbitidy as a result of increasted access. Dr. Suwit responded by =20
stating that data still need to be collected and analyzed in order to =20=

provide answers to the queries on morbidity and mortality.  Sangeeta =20
Shashikant (TWN) emphasized that in the Malaysian context, prior =20
negotations clearly did not work before Malaysia issued compulsory =20
licences for AZT, ddI and combivir in 2004.  The compulsory licences =20
achieved an 81% reduction in the price of these ARVs.  She noted that =20=

the TRIPS Agreement was quite clear that the requirement for prior =20
negotiation contained in Article 31 (of the TRIPS Agreement) was =20
waived for cases involving government use.  She also noted that =20
compulsory licenses were routinely employed in industrialized countries.

Guilherme Patriota, Counsellor from the Permanent Mission of Brazil =20
the United Nations, took the floor noting that Brazil was "to a great =20=

extent supportive and understanding" of Thailand's recent decisions.  =20=

He underscored that the fact that "Thailand made use of an instrument =20=

that was part and parcel of the IP system".  He noted that if one =20
looked back a few decades, one could observe that some countries =20
(developing and industrialized) excluded pharmaceuticals from =20
patenting.  Mr. Patriota state that after the advent of TRIPS, =20
developing countries accepted the 20 year term for patented =20
inventions including pharmaceuticals with the understanding that =20
compulsory licensing operated in concert with patent monopolies to =20
achieve a balanced system.  He stressed that the demonization of =20
countries that employed compulsory licensing was unnacceptable =20
concluding with this phrase, "stick to the bargain!"

David Vivas (ICTSD) thanked the Thai government for its initiative in =20=

writing up the 96 page White Paper noting it as a model of gentleness =20=

and transparency.  Mr. Vivas reminded the participants that =20
compulsory licensing has been part of the international architecture =20
of industrial property law since the Revision of the Paris Convention =20=

of 1925.  He pointed to a study by Professor Jerome Reichman of Duke =20
University which found that the United States was the largest user of =20=

compulsory licences with around 1000 compulsory licences issued.  Mr. =20=

Vivas noted that a compilation of national experiences with =20
compulsory licensing would be helpful to the debate.  Dr. Bale from =20
IFPMA characterized the KEI Research Note "Recent examples of the use =20=

of compulsory licenses on patents" (NEEDS url reference) as biased =20
because of its numerous references to non-health related patentes =20
including hybrid transmissions and computer technologies.  Thiru =20
Balasubramaniam (KEI) countered by noting the numerous references to =20
pharmaceutical licences in the report, in particular, the French =20
amendment to its patent law in response to the high prices of the =20
breast cancer daignostic tests charged by Myriad over the BRAC1 and =20
BRAC2 genes.  He further noted that the inter-governmental =20
organizations represented at the briefing including WHO and WTO be =20
requested to do a compilation of national examples of the use of =20
compulsory licenses on patents.

Fernando Antezana Aran=EDbar, Chair of the WHO Executive Board =20
(Bolivian national), emphasized to participants that "Thailand did =20
not have to present the 96 page White Paper, but it chose to which =20
spoke not only of transparency but to Thailand's generosity and courage"

Thiru Balasubramaniam (KEI) concluded the meeting by thanking Dr. =20
Suwit Wibulpolprasert for briefing the Geneva community and noted =20
that "Thailand was a shining example and embodiment of the spirit of =20
the Doha Declaration which called upon WTO Members to protect public =20
health and promote access to medicines for all".



----------------------------------------------
James Packard Love
Knowledge Ecology International
http://www.keionline.org
james.love@keionline.org
Washington, DC +1.202.332.2670

"If everyone thinks the same: No one thinks." Bill Walton"