|ชื่อเรื่อง||:||การศึกษาผลกระทบจากมาตรการบังคับใช้สิทธิเหนือสิทธิบัตรยาในประเทศไทยระหว่างปี 2549-2551 , Assessing the implications of the compulsory licensing policy in Thailand between 2006-2008|
|นักวิจัย||:||อินทิรา ยมาภัย , อดุลย์ โมฮารา , วันดี กริชอนันต์ , คัคนางค์ ไชยศิริ , ศรีเพ็ญ ตันติเวสส , ยศ ตีระวัฒนานนท์|
|คำค้น||:||ผลกระทบทางสุขภาพ , สิทธิบัตรยา , ยา|
|ผู้ร่วมงาน||:||โครงการประเมินเทคโนโลยีและนโยบายด้านสุขภาพ , สำนักงานพัฒนานโยบายสุขภาพระหว่างประเทศ , ไม่มีข้อมูล , ไม่มีข้อมูล , สำนักงานพัฒนานโยบายสุขภาพระหว่างประเทศ , โครงการประเมินเทคโนโลยีและนโยบายด้านสุขภาพ|
|อ้างอิง||:||9789746601139 , hs1643 , http://hdl.handle.net/11228/2843 , QV736 อ743ก 2552|
When the policy of universal health coverage was adopted in Thailand in 2001, it promised greater access to healthcare for many poor Thais who would otherwise struggle to afford treatments and pharmaceuticals. The Universal Coverage scheme provided subsidized health care for the majority of the Thai population which had hitherto not been covered by a public health insurance scheme. This coverage now entitled them to full access to drugs within the National List of Essential Medicines (NLEM). The government, subsequently in 2003, also declared its commitment to provide universal access to HIV/AIDS treatment. Several policy measures were employed by the government, in its attempt to meet its commitment to ensure access to essential drugs. The national health budget was increased, to its current level of 9% of the overall national budget in 2009, having been 7.6% in 2004, and 5.8% in 1993. Unsurprisingly, the government also sought to identify and adopt a number of cost containment measures in the face of increasing health drug expenditure, a measure not uncommon among more developed countries with public health insurance schemes. One such measure was the government’s decision to grant government use licenses for seven drugs over the period 2006-2008. The seven drugs are efavirenz (EFZ) and the lopinavir/ritonavir (LPV/r) combination (which are antiretroviral drugs); clopidogrel (for the treatment of coronary artery disease); and four anti-cancer drugs - imatinib, erlotinib, letrozole, and docetaxel. These drugs are under patent protection in Thailand, hence no generic competition exist. The government use licenses, a form of compulsory licensing by the government for the public interest, were intended to permit the import of the more affordable generic equivalents of the drugs for use in the public health system, to increase access to these drugs. Thailand’s government use of the patents on the seven drugs is an exercise of the right provided for in Section 51 of the Thai Patent Act BE 2522, which authorizes the government use of patents in the general public interest, so that “any ministry, bureau or department of the Government” may exercise the rights in any patent “to carry out any service for public consumption”. This study aims to assess impact of the government use licenses, which have been the focus of great controversy. Despite the adoption of the Doha Declaration on the TRIPS Agreement and Public Health in 2001, which affirmed the right of governments to take measures such as compulsory licensing to limit exclusive patent rights when the public health interest so demands, there has been much criticism of the grant of the government use licenses. Many of the critics challenge the legal validity of the licenses under international and domestic law, but there are those who question the motives and rationale of the grant of the licenses. They raised doubts that the government use licenses would not meet their stated objectives of increasing access to the drugs in question. There were also concerns that the political and economic costs of the grant of these licenses, in terms of trade sanctions from foreign governments opposed to the government use licenses, and of pharmaceutical companies retaliating by withdrawing or delaying drug registrations in Thailand, would far outweigh the benefits expected to be obtained from the government use licenses. Whilst much has been written about the legal and political controversies surrounding the government use licenses, there has been no study, to date, which seeks to assess the actual and potential impacts of the policy. This study therefore, conducts assessments of the health, economic and psychosocial implications of the government use licenses. In this regard, this study represents the first evidence-based attempt to assess the impact of the government use licenses, with a view to clarifying aspects of the controversy and enabling a better-informed, evidencedbased debate between the key stakeholders. Health impacts The assessment of the public health impact of the government use licenses is intended to determine or estimate the actual and expected increase in number of patients with access to the relevant drugs, and the public health benefits derived from such increased access, in terms of gains in patients’ health utility, measured in Quality-Adjusted Life Years (QALYs) gained or Disability-Adjusted Life Years (DALYs) averted. The study adopted a five-year timeframe for the assessments, commencing from the time of the grant of the government use licenses. The methodology and the findings in this respect are described in detail in Chapter 2. In summary, the study estimated the increase in the number of patients with access to EFV and LPV/r over the five-year period to be 17,959 and 3,421, respectively. For clopidogrel and the four anti-cancer drugs, the study projected an increase in number of patients with access to the drugs using estimates of patients in need of the drug minus the numbers of patients expected to receive the original drugs. The estimated increase in patients to clopidogrel was estimated to be 40,947. For the anti-cancer drugs, the estimates are as follows: 8,916 patients for letrozole; 10,813 for docetaxel, 1,846 for imatinib; and 256 for erlotinib. Given the limitations of data and the fact that importation of the generic drugs has only taken place for EFV, LPV/r and clopidogrel, further study is recommended to improve accuracy of these estimates, particularly, when data on actual number of patients with access to each drug becomes available. The public health benefits derived from such increased access, from increased life expectancy and improved quality of life was measured in the QALYs gained or DALYs averted. The study relied on a literature review of international and domestic research papers to estimate the QALYs for the use of each drug, compared to the alternative or standard treatments used prior to the grant of the government use licenses. The QALYs gained as a result of the use of the each drug in question was then multiplied against the estimated increase in patient numbers for the five-year timeframe. The results, in terms of QALYs gained (in order of drugs with the greatest health gains): 1. letrozole: a gain of 3,656 QALYs; 2. EFV: 2,694 QALYs gained; 3. clopidogrel: 2,457 QALYs gained; 4. imatinib: a total of 2435 QALYs gained (1384 QALYs for Chronic Myeloid Leukemia (CML) patients; 1051 QALYs for Gastrointestinal Stromal Tumor (GIST) patients); and 5. docetaxel: 1,251 QALYs gained There was no comparative study on utility of LPV/r and erlotinib versus alternative treatments, hence the study was not able to estimate the increase of QALYs resulting from increased access and use of these drugs. Table 2.1 summarises the projections of number of patients with access to drugs and increased health status within the study timeframe. Chapter 3 considers the health-related economic impacts of the government use licenses; through an assessment of the impact of two mutually exclusive scenarios. Scenario 1 assumes a situation of full access for all patients to the seven patented drugs, at the time of the grant of the government use licenses, and the economic impact to be assessed is the expected decrease in drug expenditure that would arise from the use of generic drugs under the government use licenses to maintain full access under the national health system. Scenario 2, on the other hand, is based on the assumption that not all patients have access to the seven patented drugs at the time of the grant of the government use licenses (reflecting the current situation), and that the government use licenses will result in an increase in access. This scenario permits a cost-benefit assessment; of the benefits, in terms of the positive impact from the increase in national productivity as a result of increased access, improved life expectancy and quality of life, and number of patients returning to work; and the costs, in terms of net changes in public health expenditure for drug procurement. In Scenario 1, the use of the generic versions of the six original drugs under government use license would result in a reduction of the national health expenditure, with the estimated cost savings of approximately 357.8 million USD for the 5-year timeframe. The anti-cancer drug, imatinib, was not included in the model, since implementation of the government use license was suspended on condition that the original drug is provided free to patients under the Novartis Glivec International Patient Assistance Program (GIPAP). While Scenario 1 does not reflect the true level of access to drugs, it is still important to assess the impact of the use of generic drugs on the national health budget, given the government’s commitment to ensure access to medicines for all patients. In Scenario 2, impact was assessed in terms of the incremental benefits to health, which was estimated to be approximately 132.4 million USD for the 5-year study timeframe. Benefits obtained under Scenario 1 exceed that of Scenario 2 for a number of reasons; first, Scenario 1 assumes access for all patients in need whereas, Scenario 2 only assessed the impact of the incremental number of patients who received accessed to treatment as a result of the government use licenses; and secondly, the comparison in Scenario 1 used the original drug versus the generic versions, while Scenario 2 also compared the use of alternative or existing drugs available prior to government use licenses]. Impact on trade and foreign investment It was widely believed that the US withdrawal of the Generalized System of Preferences (GSP) benefits from three Thai exports (i.e., gold jewellery, polyethylene terephthalate in primary forms and flat screen colour television sets) was a retaliatory measure by the US government, which had formally expressed its concerns over the grant of the government use licenses (one example of which is its elevating of Thailand to a Priority Watch List Country in its Special 301 Report of 2007). It was also a concern of domestic critics that the flow foreign investments in the country would be reduced, as a result of the negative publicity from the government use licenses. In Chapter 4, the assessment of the impacts on trade and foreign investment seeks to respond to these concerns, through an analysis of (1) the impact of the withdrawal GSP benefits for the three Thai export products, in respect of the exports of the said products in the context of Thailand’s overall export performance; and (2) the impact on foreign investment, both foreign direct investment (FDI) and short-term investments in the financial markets, in Thailand. With respect to the impact of the withdrawal of GSP benefits for the three Thai export products, the analysis found that the value of these exports to the US did decline, particularly in the case of polyethylene terephthalate in primary forms. The export value of the same products to the rest of the world, however, increased. Hence, the impact of the GSP withdrawal did not adversely affect the overall export status of the products. It was also noted that Thailand’s overall exports are expected to increase; although exports to the US are expected to decrease, exports to other countries are expected to increase, particularly those to the ASEAN countries, offsetting the decrease in exports to the US market. The total value of US exports attributable to products with GSP status is small, amounting to 7% of overall exports in 2008, and expected to decline further, implying that the GSP benefits were becoming less important. A noteworthy point is that although the GSP privilege was withdrawn for the three export products in 2007, an additional eight products were granted the GSP status in the same year, a fact which has received little attention. As regards foreign investments, data from the Thai Board of Investment indicated steadily rising FDI over the period 2002 to 2007, with a dip in 2006 following the change of government. In the current global economic slowdown, FDI levels are expected to decrease from 2008, but the study found no evidence of a link between the grant of the government use licenses and the level of FDI flow. In the same vein, the study found little evidence of a link between the government use licenses or the removal of GSP status, with changes in investor confidence. This study examined changes in activity in the Stock Exchange of Thailand (SET) Index in the seven days prior to, and after, the grant of the government use licenses and the announcement of the withdrawal of GSP status for the three products, as an indicator of the level of investor confidence in Thailand. In terms of changes in the value of the SET Index, it found that the Index seemed most responsive to the changing economic conditions of the US market, the Thai political climate and fluctuations of the Thai Baht, rather than the grant of the government use licenses. It was not possible, however, to determine longer-term impacts, given that decisions on major long-term foreign investments occur over a longer period of time. In summary, given that both short- and long-term investments are influenced and affected by a complex mix of issues, it was difficult to determine the effect of a single factor. Psychosocial implications Chapter 5 examines the psychosocial aspects related to the grant of the government use licenses. Given the controversy and debate generated by the licenses, it was thought important to gather information and better understand the views and perspectives of the key stakeholders, both Thai and international. A questionnaire survey was conducted to ascertain the following: which factors influenced the respondents’ support for, or opposition to, the government use licenses, and the perspectives of various stakeholders on the grant of government use licenses for essential drugs and on the use of other price regulation measures. The questionnaire also sought to assess respondents’ attitude towards the inclusion of the different drugs (i.e., ARVs, clopidogrel for heart disease and anti-cancer drugs) under the government use licenses. The questionnaire, was distributed to identified groups of key stakeholders, comprising health care workers, researchers/academics, policy makers and foreign stakeholders from developed and developing countries, for their completion. In brief, the survey found a correlation between the level of general knowledge regarding the TRIPS Agreement flexibilities and attitudes towards compulsory licensing, especially among those in the health, research/academic sectors and among respondents from developing countries. Those with substantial knowledge on the area were more likely to support the government use licenses, while those with less knowledge tended to oppose them. Most of the Thai and international respondents from developed countries agreed with the statement that the government use licenses were likely to improve access to antiretroviral drugs to treat HIV-infected patients. There was, however, no clear consensus as regards the grant of the licenses to improve access to drugs for treatment of patients with cardiovascular disease and cancer. These findings can be of use to policy makers, and lend support to the efforts to increase knowledge and understanding of the relevant issues, especially among health personnel and researchers/academics. In conclusion, the assessment of the public health benefits of the government use licenses is a positive one. Specifically, the government use licenses are expected to help alleviate the cost barrier to access to drugs, through importation of cheaper generic drugs, and hence, increase access to the drugs. The level of benefits gained varied according to the drug. In light of the findings, the study makes a number of policy recommendations. First, the selection of drugs when government use licenses or compulsory licensing is sought to be introduced, should adhere to a clear criteria, and six elements are proposed to be taken into consideration for drug selection. Secondly, there is also a need for a wide range of measures to support the effective use of government use licenses, including strengthening the country’s information systems relating to public health, insurance programs and intellectual property, so as to ensure the speedy registration and importation of the generic drugs under the government use licenses. Better and more timely dissemination of information regarding the use of TRIPS flexibilities and the government use licenses to the general public will also help to generate support for the licenses, but there should also be efforts to introduce other evidence-based, and appropriate options to promote access to specific essential drugs.
อินทิรา ยมาภัย , อดุลย์ โมฮารา , วันดี กริชอนันต์ , คัคนางค์ ไชยศิริ , ศรีเพ็ญ ตันติเวสส , ยศ ตีระวัฒนานนท์ . (2552). การศึกษาผลกระทบจากมาตรการบังคับใช้สิทธิเหนือสิทธิบัตรยาในประเทศไทยระหว่างปี 2549-2551.
นนทบุรี : สถาบันวิจัยระบบสาธารณสุข.
อินทิรา ยมาภัย , อดุลย์ โมฮารา , วันดี กริชอนันต์ , คัคนางค์ ไชยศิริ , ศรีเพ็ญ ตันติเวสส , ยศ ตีระวัฒนานนท์ . 2552. "การศึกษาผลกระทบจากมาตรการบังคับใช้สิทธิเหนือสิทธิบัตรยาในประเทศไทยระหว่างปี 2549-2551".
นนทบุรี : สถาบันวิจัยระบบสาธารณสุข.
อินทิรา ยมาภัย , อดุลย์ โมฮารา , วันดี กริชอนันต์ , คัคนางค์ ไชยศิริ , ศรีเพ็ญ ตันติเวสส , ยศ ตีระวัฒนานนท์ . "การศึกษาผลกระทบจากมาตรการบังคับใช้สิทธิเหนือสิทธิบัตรยาในประเทศไทยระหว่างปี 2549-2551."
นนทบุรี : สถาบันวิจัยระบบสาธารณสุข, 2552. Print.