trips+ of ftas to trips+ without fta: pharmacopolitics in thailand

1
p!0.001). A significantly lower proportion of patients from WA compared to EA chose the GP (9.7% vs. 16.5%, p!0.001). As for advice provision on medica- tion use, pharmacists provided the most advice (WA:52.8% vs. EA:53.0%, p¼0.224), followed by the specialist (WA:32.0% vs. EA:27.4%, p!0.001). The second part of the questionnaire revealed that patients expect brief counselling (2 minutes) on medication use from their pharmacist (WA:81.3% vs. EA:83.1%, p¼0.216). A small proportion of patients (WA:18.2% vs. EA:20.0%, p¼1.07) perceived the need for a paid Medication Management Review (MMR) service. Conclusions: Patients have high perception of the role of the pharmacist in Jordan, being the most accessible health care professional in the country. The role of the GP seems to be diminished. The low proportion of patients who perceived the need for a paid MMR service shows that this concept is not yet established in the Jordanian community. ORAL PRESENTATION 2: POLICY, REGULATION AND ECONOMICS TRIPS+ of FTAs to TRIPS+ without FTA: Pharmacopolitics in Thailand K. Kijtiwatchakul 1 , N. Tien Udom 2 , 1 Coordinator of FTA Watch, Thailand, 2 Director of AIDS Access Foundation Objectives: To study the tactics of policy interference by multinational pharmaceutical industry and the strategic movement by the multinational pharmaceutical industry that lobbies policy makers to manipulate Intellectual Property Rights protection for its profit, regardless of FTA negotiations. Methods: Literature review; in-depth interview; and focus group discussion. Results: While the Thai-US FTA negotiation has been suspended since 2006, the Thai-EU negotiation has not started yet. Thus, Thailand has not officially accepted the more high standard of Trade Related Intellectual Property Right protection (TRIPS plus) provision of which might have an adverse effect on access to medicine and health care. According to an impact analysis, if the Thai-US FTA’s TRIPS plus provision be accepted, the total cost of a lifetime treatment of HIV/AIDS patients would be escalated, resulting in a tremendous increase in government health care budget. Moreover, the TRIPS plus would have devastating impacts on many areas of laws, including those governing patents. Patent laws would be strengthened under this FTA, making it more difficult for these countries to access affordable, quality, and life-saving medicines. However, even if the Thai FTA negotiations are interrupted, aggressive lobbying for TRIPS plus provisions is continuously pursued. Thai government is pressured to amend Thai laws or regula- tions through different approaches by multinational pharmaceutical corporations. These drug corporations are manipulating behind the controversial movement by some conservative and profit-oriented physicians attack- ing the quality of generic medicines and delaying the quality improvement process in granting IPR aiming to prevent the so-called ‘evergreening patent’. Conclusions: Although FTA negotiations are pending, and the TRIPS plus are not yet be accepted, situation on the threat by pharmaceutical industry on Thai health system is still going on unabated. Thus, public surveil- lance on these movements is necessarily crucial by the FTA watch (a coalition of Thai non-government orga- nizations working on FTA) and the NGOs working on access to medicines. EvergreeningÔ Patent: Playing Monopoly with Minor Incremental Development of Pharmaceuticals in Thailand N. Kessomboon 1 , U. Maleewong 2 , K. Kijtiwatchakul 2 , A. Eksaengsri 3 , S. Atsawintarangkun 3 , J. Limpananont 4 , 1 Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand, 2 Independent Researcher, Thailand, 3 Government Pharmaceutical Organization, Bangkok, Thailand, 4 Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok, Thailand Objectives: To explore the situation of ‘evergreening’ of pharmaceutical patents in Thailand during 2000-2010. Methods: The pharmaceutical patent applications during 2000-2010 were re-examined by using the guideline for the examination of pharmaceutical patents in Thailand. The guideline was developed from the guideline elaborated by the International Center for Trade and Sustainable De- velopment, the United Nations Conference on Trade and Development, and the World Health Organization (2007) and adopted from the focus group discussions among key informants including academics; the Department of Intel- lectual Property, Ministry of Commerce; Pharmaceutical Research and Manufacturers Association; and Thai Phar- maceutical Manufacturers Association. The patent appli- cation examiners were also standardized until reaching the almost perfect agreement among the examiners (kappa coefficient ¼ 0.89). Results: Patents over minor incremental developments (often termed as ‘evergreening’ patents) may be used to exclude generic competition and thereby block access to affordable drugs. Of the 2,034 patent applications during 2000-2010, 1,960 were categorized as ‘evergreening’. The ‘evergreening’ ranged from new use of a known sub- stance (73.7%), formulations (36.4%), markush claims (34.7%), and combinations (15.2%). Top three of the patent application holders, (58.2%) in Thailand were e23 Abstracts / Research in Social and Administrative Pharmacy 8 (2012) e1–e66

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Page 1: TRIPS+ of FTAs to TRIPS+ without FTA: Pharmacopolitics in Thailand

e23Abstracts / Research in Social and Administrative Pharmacy 8 (2012) e1–e66

p!0.001). A significantly lower proportion of patients

from WA compared to EA chose the GP (9.7% vs.

16.5%, p!0.001). As for advice provision on medica-

tion use, pharmacists provided the most advice

(WA:52.8% vs. EA:53.0%, p¼0.224), followed by the

specialist (WA:32.0% vs. EA:27.4%, p!0.001). The

second part of the questionnaire revealed that patients

expect brief counselling (2 minutes) on medication use

from their pharmacist (WA:81.3% vs. EA:83.1%,

p¼0.216). A small proportion of patients (WA:18.2%

vs. EA:20.0%, p¼1.07) perceived the need for a paid

Medication Management Review (MMR) service.

Conclusions: Patients have high perception of the role of

the pharmacist in Jordan, being the most accessible

health care professional in the country. The role of the

GP seems to be diminished. The low proportion of

patients who perceived the need for a paid MMR service

shows that this concept is not yet established in the

Jordanian community.

ORAL PRESENTATION 2: POLICY, REGULATIONAND ECONOMICS

TRIPS+ of FTAs to TRIPS+ without FTA:Pharmacopolitics in ThailandK. Kijtiwatchakul1, N. Tien Udom2, 1Coordinator of FTA

Watch, Thailand, 2Director of AIDS Access Foundation

Objectives: To study the tactics of policy interference by

multinational pharmaceutical industry and the strategic

movement by the multinational pharmaceutical industry

that lobbies policy makers to manipulate Intellectual

Property Rights protection for its profit, regardless of

FTA negotiations.

Methods: Literature review; in-depth interview; and

focus group discussion.

Results: While the Thai-US FTA negotiation has been

suspended since 2006, the Thai-EU negotiation has not

started yet. Thus, Thailand has not officially accepted

the more high standard of Trade Related Intellectual

Property Right protection (TRIPS plus) provision of

which might have an adverse effect on access to medicine

and health care. According to an impact analysis, if the

Thai-US FTA’s TRIPS plus provision be accepted, the

total cost of a lifetime treatment of HIV/AIDS patients

would be escalated, resulting in a tremendous increase in

government health care budget. Moreover, the TRIPS

plus would have devastating impacts on many areas of

laws, including those governing patents. Patent laws

would be strengthened under this FTA, making it more

difficult for these countries to access affordable, quality,

and life-saving medicines. However, even if the Thai

FTA negotiations are interrupted, aggressive lobbying

for TRIPS plus provisions is continuously pursued. Thai

government is pressured to amend Thai laws or regula-

tions through different approaches by multinational

pharmaceutical corporations. These drug corporations

are manipulating behind the controversial movement by

some conservative and profit-oriented physicians attack-

ing the quality of generic medicines and delaying the

quality improvement process in granting IPR aiming to

prevent the so-called ‘evergreening patent’.

Conclusions: Although FTA negotiations are pending,

and the TRIPS plus are not yet be accepted, situation on

the threat by pharmaceutical industry on Thai health

system is still going on unabated. Thus, public surveil-

lance on these movements is necessarily crucial by the

FTA watch (a coalition of Thai non-government orga-

nizations working on FTA) and the NGOs working on

access to medicines.

Evergreening� Patent: Playing Monopoly with MinorIncremental Development of Pharmaceuticals inThailandN. Kessomboon1, U. Maleewong2, K. Kijtiwatchakul2, A.Eksaengsri3, S. Atsawintarangkun3, J. Limpananont4,1Faculty of Pharmaceutical Sciences, Khon Kaen

University, Khon Kaen, Thailand, 2Independent

Researcher, Thailand, 3Government Pharmaceutical

Organization, Bangkok, Thailand, 4Faculty of

Pharmaceutical Sciences, Chulalongkorn University,

Bangkok, Thailand

Objectives: To explore the situation of ‘evergreening’ of

pharmaceutical patents in Thailand during 2000-2010.

Methods: The pharmaceutical patent applications during

2000-2010were re-examined by using the guideline for the

examination of pharmaceutical patents in Thailand. The

guideline was developed from the guideline elaborated by

the International Center for Trade and Sustainable De-

velopment, the United Nations Conference on Trade and

Development, and theWorld Health Organization (2007)

and adopted from the focus group discussions among key

informants including academics; theDepartment of Intel-

lectual Property, Ministry of Commerce; Pharmaceutical

Research andManufacturersAssociation; andThai Phar-

maceuticalManufacturers Association. The patent appli-

cation examiners were also standardized until reaching

the almost perfect agreement among the examiners

(kappa coefficient ¼ 0.89).

Results: Patents over minor incremental developments

(often termed as ‘evergreening’ patents) may be used to

exclude generic competition and thereby block access to

affordable drugs. Of the 2,034 patent applications during

2000-2010, 1,960 were categorized as ‘evergreening’. The

‘evergreening’ ranged from new use of a known sub-

stance (73.7%), formulations (36.4%), markush claims

(34.7%), and combinations (15.2%). Top three of the

patent application holders, (58.2%) in Thailand were