Às “nơ other issue so clearly epitomize theclash between lumen rights and intellectual property as access to patented medicine”, fostering innovation through petent sights and enswing ac
walk from the homes of the population."
‘The first document which clsely included access to medicines as e past of the sight tobealth wasthe Alme-Ata Declaration which statedthet prim ery health careincludes
“at least [ ] a provision of essential drugs” 3 Access to medicine is protected by
‘The Internetional Covensnt on Economic, Social and Cutval Rights (ICESCR) es
‘an integral part of the right to health conteined in Article 12 of ICESCRTM, which seeds
“(1) The States Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
(2) The steps to be taken by the State Parties to the present Covenant to achieve the full realization of this right shall include those necessary for:
(@) The provision for the reduction of the stillbirth-rate and of infant mortality and _for the healthy development of the child:
(©) The improvement of all aspects of envirormental and industrial hy giene,
(©) The prevention treatment and control of epidemic, endemic, occupational and other diseases
(3) The creation of condhtions which would assure to all medical service and medical
‘attention in the event of sieloese
‘MDG Gap Task Farce Report, MGllennisa Develomment Goel: ‘Delivering onthe Gibal Pumersip for Achievng he MHlerssea Development Gous'(2008) UN publictim, eile:
Ip Jaron m orginlemamagoel ba MDG Gap Thức Farce Repar 3008p [MDG Peper 2008],p 3%
Aims Aa Declaration A202), Art Vidatp 4 and pare 16 arp 28
‘The duties thet the sights of the Covenant impose on States Pasties are put for ardin.
“Bach State Party to the present Covenant overtakes to take steps, indivichally and through international assistance and co-operation especially economic and technical, to the maximum of its available resources, with a view to achieving progressively the full realization of the rights recognized in the present Covenant by all appropriate means, including particularly the adoption of legislative measures.
‘Therefore, within the contert of medicines, states must create and implement ô seasonable action program to continuously improve access to essential medicines.
State responsiblity to provide estentiel medicines should be secognized in domestic lew end given priority for public financing through aufficient budget allocation Laws end policies within the health system (2, for universal health coverage or medicines pricing) and the broader legal order (i for trade or intellectual property protection) should be aligned with echieving universal access to essential medicines.
1.14 The elements of human rights to health and access te medicine
‘The sight to health, as stetedin the General Comment No 14, contains four essential and inter-related elements: Availability, accessibility, acceptability and quality (the
AAAQ)
In complement to the “AAAQ" framework described above, WHO has outlined the following fow key building blocks as essential toward ensuing access to medicines ination health systems?”
“1, Rational selection and use of essential medicines, based onnational lists of essential medicines and treatment guidelines,
2 Affordable prices for goverrments, health care providers and individuals,
Commitee on Econamic, Social aul Culnral Fights (CESCR), Gaural Conant No 14 an the righ to
‘he highest atanable san of heal, 11 August 2000, UN Doc E/C 12/0004 para 124d
"WHO, ‘Sigutble Acces to Brent Medicaer: A Bamewars fr Collective Aton” m WHO Policy apectives on Medicines Buletn(2004) ip Japs he athneic docs ft s40624/s4062e at, 2
3 Fair and sustainable financing of essential medicines as part of the national health care system through adequate fioding levels and equitable prepayments systems, to ensiae that the poor are not disproportionately affected by medicine prices; and
4 Reliable health and supply systems to ensure sufficient and a locally appropriate combination of public and private service providers, "28
‘The right to access to essential medicines requires from Stetes to rospeot the eforementioned “AAAQ stendad” regudng essential medicines ® Firstly, eveilebility of essential medicines enteils thatthe essentiel medicines are available in sufficient quantity to everyone within the State The availability of essential drugs as
‘fumansight only pertains to the WHO Model List of Essential Medicines, whichis updated every two years based on the cwrent condition of each region `? Secondly, accessibility means that the medicines need to be accessible to everyone without
&scrimination of eny kind It includes physical accessibility, mesning thet medicines need to be within safe physical reach for everyone, including the past of the populstion living in rural areas, as well as persons with disebilities Moreover, accessibility encompasses economic accessibility or affordability, which means that medicines need to be affordable to all, including socielly disadvantaged parts of the populstion, based on equity, which implies thet “poorer households should not be
&sproportionstely burdened with health expenses as compared to sicher households”
Accessibility comprises accessibility of information, meaning thet everyone should hhave equal access to informetion selatingto health issues However, this accessibility of information should not sent in en infingsment of the confidentiality of personal health records The third element of the sight to access to medicines is their acceptability or appropriateness, This element requires thet all medicines need to be cthicelly end culturally eppropriste aswell as “designed to respect confidentiality and improve the health status of those concerned’ Finally, essentiel medicines need to
'be of good quality and “scientyically and medically appropriate *
—————T ` ° GESCR GỂ No 14,pars 12; Hesemueye al),p 105 CESCR GCNo.14,pare 12 6-8)
‘The sight of patent ie one of the most impostant legal institution under the intellectual property lew regime Protection of patent is a recognition of IP manifested in invention.
‘Throughout their long history, patents performed their role es mesns to promote the industriel advancement, represent strong and effective incentives for future production of new inventions endfor the disclosure of useful inform ation by granting sesticteel monopoly sights to patent owner
‘World Intellectual Property Orgenizetion (WIPO) has put forwerd a definition on patent as “an exclusive right granted for an twention which is a product or a process that provides, in general, a new way of doing something or offers a new technical solution to a problem To get a patent, technical information abott the invention must be disclosed tothe public in a patent application”
Another definition by L Bentley and B Sherman is that: A patent can be defined as
“a limited monopoly that is granted in rehzn for the disclosiwe of technical information” >
Generally spesking,ô patent provides the patent owner or his assignees with the sight to decide how - or whether - the invention can be used by others for a certain period of time, Patent sights are therefore regarded as & negetive sights to stop other from performing certain acts in relation to the patent owner, rether then a positive sight pertaining duties related to the invention TM
‘rte, itp Tro ipo wept!
`L Bailey nd B Sun, biailctal Propet Law Grd Baki, 2009), OUP p 335
>Ven Anh Le, Canpulbory Been Licensing and Accesso Medicmas: A Siver Bullet Agpronch to PablicHela?
A patent is evarded for an invention, which satisfies the eiterie of global novelty, non-obvioumess, end industrial or commercial epplicetion Three types of patents can be identified, namely, product petents (pstents on the product itsel), process patents (Which protect the process used to produce a produc) andthe so called “new use patents” (which protect a pasticular use of a patent) 3Ÿ
Patent sights ere only granted for a limited term, commonly 20 years from the filing of the pplication Some countries impose additional limits on patent rights One common such limit is a “local working requirement’, obliging the petentes to actuelly memufacture the protuct or use the process within the country of the grant Another one is the governmental grant of compulsory licenses under certein ciscumstences Such & license allows a third party to use the patent without the consent of the patentee, usually in return for a reasonsble fee 35
In order to be granted a petent for an invention, the inventor needs to prove thet his invention, belonging to any field of technology, is new, involves an inventive step andis susceptible of industiial application
To be eligible for patent protection, the invention must be “new” The concept is
‘understood in many jurisdictions to mean thet the cleimed invention shows a new characteristic which hes not alzeady been disclosed to the public before the relevent dete in the body of existing knowledge in its technical field (called “prior at” or
“state of the ast”) An invention is no longer new if i is past of the price art, ie if it thas already been available to the public anywhere in the world, Members show some minor differences in how they approach the concept of novelty in the reginal and ational IP system.
‘Ganda Nath Sửa and Seip Maclay, tect propery rights: An over and auplictons 3ì henmacodicd nasty
` Hoeennsyn, Holger, Hm Fights andthe WTO: Th Cast of Petts tổ Arcessto Medicines, Jbemational Elonamic Law Series (Oxford, 2008; nine edn, Onfard Academic, Jen
2009) ps: ag/l01093,cpref 0508 790199552177 001 0001, accessed 6 Ml 2024
‘The benefits granted by patent law should not be granted too easily An invention can
‘be new and yet ít constitutes only a minor change over the prior ert Therefore, it đem ends that the invention involve an “inventive step”, which ise test thet ensures thet the novel feature of an invention is not bivial and adds a useful technical cffect The terminology of non- obvioumess used in the United States is regarded as
‘identical e the tam “inventive step” Most counties apply an abstract definition of ifthe differences between the subject the requirement thet negates non-obvioumess ater sought to be patented and the prior art ave such that the subject matter as a whole would have been obvious atthe time the invention was made to aperson having ordinary skill in the art to which said subject matter pertains” Nevestheless, state practice in the epplicetion of such a definition differs significently from country to country The definition shows that the inventive step is judged by establishing the differences between the scope and content of the prior art and the patent claims and evaluating them in light ofthe ordinery sill inthe ext
CPTPP 'S
5 Hag Kin, “Seg đặt cấn nen grờivi gyàn gởi nộ cấy cin ý hấp hit chọc php 9 Hos Nena Onn Rhhr 2000 a
‘This chapter discusses how humen sights lew and international agreements like
‘TRIPS can be used to promote access to medicine Stetes can use flexibilities under Human Rights Law end TRIPS Flexibilities under Article 6, 27(1), 30, 31 and compulsory lisence to belance intellectual property sights with public health needs
‘Thailand South ABica, and Brazil used compulsory licenses to ensure access to HIV medications despite industry resistence These cases highlight the potential end chellenges of using this flexibility
Overall, Vietnam's IP lew complies with internetional agreements like TRIPS, CPTPP which set minimum standards for patent protection Vietnam's lew allows issuing compulsory licenses for generic drug production in specific stuations.
However, Vietnam can improve its IP lew to better balance the interests of inventors end public health by adjusting patent term for pharmaceuticals due to delays in epproving drug distribution registrations and clesifying patentability of new uses of known products
‘Traditionally, intellectual propesty and human sights have developed es seperste legal systems, with their own foundetions, enelyses, and epplications However, the growing importance of both areas has led to their boundaries overlapping This overlap has crested conflicts between counties end pharmaceutical compenies regarding the balance between legitimate lrumen sights to health and intellectual property rights to petent It is evident thet, the impact of strong petent protection, for instence, uader TRIPS could have strong influence on sccess to medicine, especially in developing counties such as Theilend, Brezil, South Africe
‘This Thesis has examined the complex relationship between the sight to health and petent sights under the perspective of both hurnan sight and IPRs regime It can be seen thet, rather than a human sight, IPRs, including patent, should be view as instrument of human sight Thus, counbies can incorparste a sight to health perspective into the design, implementetion intespretaion, end enforcement of their
"netional patent laws to sim for balance in amen sights to heelth end sights to patent
‘The ongoing debate on intellectual property and access to medicines necessitates continuous evaluation end adaptation of legel frameworks Vietnam, by adopting the recommendations outlined in this thesis, can strive for amore belenced approach that fosters innovation while safeguarding the fundamental sight to health for its citizens.
Vietnem cen ulilize flexibilities within TRIPS, such as compulsory licensing, to ensure access to essential medicines, implement policy changes to address delays in eug distribution registration, potentially edjusting patent terms for pharmaceuticals end clarify the patentabilty of new uses of known products to avoid hindering generic eug production es solutions to cope with the conflict
1 The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), 1994
2 The Universal Declaration of Human Rights (UDHR), 1948
3 Thelntemetional Covensnt on Economic, Social and Cultural Rights (CESCR), 1966
4 UN, Charter of the United Netions, 24 October 1945
5 UN, Sub-Commission on Human Rights resolution 2000/7, “Intellectual
‘property sights and lumen sights”
6 Declaration of Alma-Ata, International Conference on Primary Health Care, Almaty, Kezekh Soviet Socialist Republic, Soviet Union 6-12 September 1978
7 The EU-Vietnsm Free Trade Agreement EVFTA), 2019
8 The Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), 2018
9 UN Committee on the Rights of the Child (CRC), General comment No 17 (2013) on the right of the child to rest, Ieiswe, play, recreational activities, cultural life and the ests, CRC/CIGCAT
10, UN Economic andSociel Council, General Comment No 14: The Right tothe Highest Atteinable Standard of Heelth (Ast 12 of the Covenant), E/C.12/2000/4
11.DS 114, Canada — Patent Protection of Pharmaceutical Products ©) Books, legal articles, research pap ers
12 Lea Shaver, The Right to Science and Culture, Wisconsin Law Review, 2010
13 Repost of the Special Reppostew in the field of cultucal sights, Farida Shaheed, Patent policy and the sight to science and culture ,A/70/279 (2015)
14, UNCTAD-ICTSD, Resource Book on TRIPS and Development, Cambridge University Press, 2005
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18, Peter Rot, Patentrecht und Sozielpolitik unter dem TRIPS-Abkommen (2002)
19.WTO Ministerial Conference, Declaration on the TRIPS Agreement end Public Health, adopted on 14 November 2001, WT/MIN(01)/DEC/2 20 November 2001)
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31 Peter Drehos, The Universality of Intellectual Property Rights: Origins andDevelopment in Intellectual Propesty and Human Rights (Proceedings of ôPanel Discussion held by the World Intellectual Property Oxgenizetion in colleborstion with the Office of the UN High Commissioner for Hum en Rights,9 November 1998), 13-14
39.UN GAOR, Commission on Human Rights, Cube, France, Mexico: Joint Amend ent to Article 25 of the Draft Declaration (E/B00), Dreft International Declerstion of Humen Rights, 3rd Sess, UN Dos AIC 3/360 (1948)
38 Aurora Plomer, The Human Rights Parador: Intellectual Property Rights and Rights of Access to Science, Human Rights Quarterly, Vol 35, No 1 (February 2013), pp 143-175 (33 pages), The Johns Hopkins University Press
34, Moeckli D, Shah 8, and Sivakumaren S, International Human Rights Law, 3đ eda, (OUP 2018)
35.Report on the Twenty-Fifth Twenty-Sixth end Twenty-Seventh Sessions:
Statement by the Committee on Economic, Social and Cultural Rights on Human Rights and Intellectual Property Annexwe XII, { 4, UN Doc B/0002/22-E/C 12/2001/17 (2001)
36.R von Jhering, Der Zweck im Recht, Exster Band (4th edn, 1904) V
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438 HE Bale, Jr, Patents, Patients and Developing Countries: Access, Innovation and The Political Dimensions of Trade Policy in B Granville (ed), The Economics of Essential Medicines (2002)
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40.Commission on Human Rights Access to medicetion in the contest of pandemics such as HIV/AIDS, Resolution 2001/53 (23 April 2001)
41, WTO ANALYTICAL INDEX GATT 1994 — Article XX (D8 report), 1.4.4
42, Akhtar G Indian pharmaceutical industry en overview IOSR J Humanit Soc Sei .2013,13:51-66.
43.Ford, N., Patents, access to medicines and the sole of non-governmental erganisations, Joumnel of Generic Medicines, Vol 1, No 2 sr
44,Colline Chase, C.T., The case against TRIPS-plus protection in developing countiies facing AIDS epidemics, University of Pennsylvania Joumal of International Law, Vol 29, No 3, 2008
45.Bond, P., Globalization, pharmaceutical pricing and South African Health Policy: Managing confrontation with U 8 firms and politicians, International Journal of Health Services, Val 29, No 4, 1999
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47 Stephen Masks, Humen Rights: A Brief Introduction, Harvard University
48 Rosalyn Higgins, Problems and Process, International Law and How We Use It(QUP: Clarendon Press 1994)
49 Hunt, Lynn 2007: The Paradoxical Origins of Hum an Rights, in: Wasserstrom, IN etal (eds): Human Rights and Revolutions 2nd ed, London: Rowman and Littlefield,
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55 Chandra Neth Sehe and Sanjib Bhattacharya, Intellectusl property sights An overview and implications in phermeceutical industry
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63 Vincenzo Denicold, Luigi Alberto Frenzoni, The contract theory of patents, International Review of Law and EconomicsV olume 23, Issue 4, December 2003
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BO TU PHAP CONG HÒA XÃ HỘI CHỦ NGHĨA VIỆT NAM
‘TRUONG ĐẠI HỌC LUẬT HÀ NỘI Độc lập - Tự do - Hạnh phúc
PHIEU DANH GIÁ KHÓA LUẬN TOT NGHIỆP
(Dành cho giảng viên hướng dẫn)
Ho và tên người nhận xét: Phạm Minh Huyễn Đơn vị công tác: Khoa Pháp luật Dân sự - Trường Dai học Luật Ha Nội
“Tên sinh viên; Lê Thuỷ Duong Lớp: 4502
"Tên đề tải khóa luận: Interface between patent rights and human rights to health in light of international law and suggestions to Vietnam Intellectual property law
“Thuộc chuyên ngành: Luật Sở hữu trí tuệ
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BỘ TƯ PHÁP CONG HÒA XÃ HỘI CHỦ NGHĨA VIỆT NAMTRUONG ĐẠI HỌC LUẬT HÀ NỘI Độc lập - Tự do - Hạnh phúc.
BIEN BẢN ĐÁNH GIÁ KHÓA LUẬN TOT NGHIỆP
(Dành cho thư ký Hội đồng)
Ten sinh viên: Lê Thuỷ Dương Mã số SV: 4502 Tên đ tài nghiên cứu: Interface between patent rights and human rights to health in light of international law and suggestions to Vietnam Intellectual property law
"Tổng số thành viên Hội ding: 03 Cómặt:03 Ving: 00
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‘TRUONG ĐẠI HỌC LUẬT HÀ NỘI "Độc lập - Tự do - Hạnh phúc.
PHIẾU ĐÁNH GIÁ KHÓA LUẬN TOT NGHIỆP
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Thanh công va hạn chế của khóa
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Khóa luận: yêu cầu của một khóa luận tốt nghiệp Đại học. Điểm bằng số. Điểm bằng chữ:
Ha Nội, ngày 7 tháng À năm 2024
BỘ TƯ PHÁP CONG HOA XÃ HỘI CHỦ NGHĨA VIỆT NAM TRUONG ĐẠI HỌC LUAT HÀ NỘI "Độc lập - Tự do - Hạnh phúc
PHIEU DANH GIÁ KHÓA LUẬN TOT NGHIỆP
(Đành cho thành viên hội đẳng)
Họ và tên người nhận xế: Vương Thanh Thuỷ
Chức định rong hội đồng: Uý viên
Bom vị công tác: Khoa Pháp It Dân sự Trường Đại bọc Luật Hà Nội Hạ ten sinh viên: Lê Thuỷ Dương La 4502
“Tên dé ti khóa luận: Interface between patent rights and human rights to health in Fight of ntemational law and suggestions to Vietnam Intellectual property law
_Ngành/chuyên ngành: Luật Sở hữu tri tuệ: ¥ kiến nhận xết
1 Sự cần thiết của việc nghiên cứu để tải khóa luận
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Sự phù hợp với ngành, chuyên ngành; sự không tring lap về đề tải, nội dung, kết quả nghiên cứu với các công tinh đã được công bổ
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Tinh trung thự, minh bạch trong trích dẫn tư iu; bổ cục và hình thức tình bày
Nội dụng, phương pháp, kết quả, ý nghĩa, độ cậy của các kết quả đạt được
Câu hỏi phản biện (sinh viên tra lời trước Hội
Mid os Maan yêu cầu của một khóa luận tốt nghiệp Dai học. Điểm bằng số Điểm bằng chi
Ha Nội, ngày É thắng S năm 2024
BỘ TUPHAP CONG HOA XÃ HOI CHỦ NGHĨA VIET NAM
TRUONG ĐẠI HỌC LUAT HÀ NỘI Độc lập - Tự do - Hạnh phúc
PHIEU ĐÁNH GIÁ KHÓA LUẬN TOT NGHIỆP
(Dinh cho thành viên hội đồng)
Ho và tên người nhận xét, Vũ Thị Hải Yến Chức danh trong hội đồng: Chủ tịch
Don vi công tác: Khoa Pháp luật Dân sự - Trường Đại học Luật Hà Nội
Ho tén sinh viên: Lê Thuy Dương Lớp: 4502
“Tên đề tai khóa luận: Interface between patent rights and human rights to health in light cof intemational law and suggestions to Vietnam Intellectual property law 'Ngành/chuyên ngành: Luật Sở hữu trí tug Ý hiến nhận xét 1 Sự cần thiết của việc nghiên cứu để tài khóa luận: cá -
2 Sự phù hợp với ngành, chuyên ngành; sự không ring lp về đ di, quản công trình đã được công bổ: nội dụng,
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