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Rätten till hälsa och tillgång till patenterade läkemedel

Larenas, Christian LU (2015) JURM01 20151
Department of Law
Abstract
At the moment of writing approximately two billion people around the world lacks adequate access to essential medicines. Furthermore approximately forty thousand people dies every day because of lack of access to essential medications. Mostly the affected populations are located in the developing countries. The availability of essential drugs has thus become a weapon to fight diseases affecting humans in developing countries. The right to health is declared in Universal Declaration of Human Rights (UDHR) and précised in CESCR. According to CESCR the right to health shall be achieved by the States parties through a progressively requirement. However, there is no judicial enforcement for the State parties not fulfilling the requirements in... (More)
At the moment of writing approximately two billion people around the world lacks adequate access to essential medicines. Furthermore approximately forty thousand people dies every day because of lack of access to essential medications. Mostly the affected populations are located in the developing countries. The availability of essential drugs has thus become a weapon to fight diseases affecting humans in developing countries. The right to health is declared in Universal Declaration of Human Rights (UDHR) and précised in CESCR. According to CESCR the right to health shall be achieved by the States parties through a progressively requirement. However, there is no judicial enforcement for the State parties not fulfilling the requirements in CESCR. Furthermore, the wording of the progressivity requirement in CESCR is vague and the determination on how the progressivity requirement is to be interpreted is left to the States parties to decide. The result ought being that the right to health declared in CESCR results in an obligation for the States parties to achieve the highest possible right to health for its citizens.

There is a conflict in international law between the regulations for patent protection for medicines and the regulations stipulating the right to health. Developing countries cannot afford to pay for essential medication to the pharmaceutical companies that mostly also are the patent owners. Patent protection is regulated in TRIPS which also contains exceptions to the exclusiveness of the patent right. Examples of exceptions for developing countries to the exclusiveness of patents are mainly the regulations in TRIPS for parallel imports and compulsory licensing. None of the exceptions has so far been proved to be effective as it is unclear to what extent the TRIPS regulations covering the exemptions for patent protection do apply. Furthermore the developing countries lacks the knowledge and have not the economic resources required in order to utilize the compulsory licenses. Nevertheless, attempts have been made to expand and clarify the TRIPS exemptions in an effort to reach for coexistence between patent protection and access to essential medications. Additionally an efforts to coexistence was initiated via the Doha Conference recognizing the developing countries' need for assistance. The outcome of the DOHA conference was that art. 6 DOHA gave the TRIPS Council the mandate to submit solutions to the conflict between TRIPS and the right to health. This was done by WTO via the General Decisions from year 2005. The WTO´s General Council decision has however still not been accepted by the States parties on which the decision still today is not into force. Moreover the right to health and patent law seems not being compatible as long as free trade agreements between developed and developing countries contains rules extending the patent protection beyond what is stipulated in TRIPS, also known as TRIPS plus rules. The free trade agreements also often stipulates restrictions on compulsory licensing and parallel imports beyond TRIPS regulations.

The free trade agreements weakens the ability of developing countries to gain access to essential medicines and are also increasing the approximation between the patent protection in TRIPS and the right to health in international treaties.
The way forward for decreasing the gap between patent protection and the right to health could be realised if the State parties approved the General Council Decision with its increased flexibilities for TRIPS. Furthermore, the continuing involvement of the human right institutions that promotes the expansion of human right provisions at the WTO conferences is also a vital requirement for an extension of human rights regulations into the WTO regulations. A WTO treaty proclaiming human rights would be an optimal way of proceeding heading towards a balance between the regulations.

Finally, the possibility for coexistence between patent protection and the right to health is in the prevention of the TRIPS plus clauses in the free trade agreements. Also the re-negotiation of the existing free trade agreements stipulating TRIPS plus rules would be beneficial for the co-existence. It would indeed also help if the General Councils decision was approved by 2/3 of the States parties. The new deadline for decision making is set for 31 December 2015. In case the General Councils decision is accepted by 2/3 of the State parties it might give us the possibility to know more about the effects of the suggested art. 31 bis TRIPS. The acceptance of the decision might in time also indicate how the flexibilities in TRIPS can be further developed and also how the effects of the changes are recognised by the State parties and the international community. In case the State parties once again doesn’t accept the General Councils decision, the timeframe for acceptance may be extended by the UN General Council. With that being said, 31 December 2015 could therefore be an important date to keep in mind with regard to patent protection and right to health’s potential co-existence. (Less)
Abstract (Swedish)
I skrivande stund saknar ca två miljarder människor adekvat tillgång till essentiella mediciner och ca fyrtio tusen människor dör varje dag på grund av brist på tillgång till essentiella mediciner. Främst drabbas människor i u-länder.

Tillgången till essentiella mediciner har således blivit ett vapen för att bekämpa sjukdomar som plågar människor i u-länder. Rätten till hälsa manifesteras i FN: s allmänna förklaring om de mänskliga rättigheterna (UDHR) samt preciseras i CESCR. Rätten till hälsa ska enligt CESCR uppnås av konventionsstaterna progressivt, dock finns det inga judiciella effekter för de konventionsstater som inte uppfyller kraven i CESCR. Kravet på progressivitet är vagt formulerat och bestäms av konventionsstaterna samt... (More)
I skrivande stund saknar ca två miljarder människor adekvat tillgång till essentiella mediciner och ca fyrtio tusen människor dör varje dag på grund av brist på tillgång till essentiella mediciner. Främst drabbas människor i u-länder.

Tillgången till essentiella mediciner har således blivit ett vapen för att bekämpa sjukdomar som plågar människor i u-länder. Rätten till hälsa manifesteras i FN: s allmänna förklaring om de mänskliga rättigheterna (UDHR) samt preciseras i CESCR. Rätten till hälsa ska enligt CESCR uppnås av konventionsstaterna progressivt, dock finns det inga judiciella effekter för de konventionsstater som inte uppfyller kraven i CESCR. Kravet på progressivitet är vagt formulerat och bestäms av konventionsstaterna samt utmynnar i en skyldighet för konventionsstaterna att försöka uppnå den högsta möjliga rätten till hälsa för sina medborgare.

Det råder en konflikt inom den internationella rätten mellan patentskydd för mediciner och rätten till hälsa. U-länder har indikerat att de inte ha råd att betala läkemedelsföretagen tillika patentägarna för de essentiella medicinerna men kan samtidigt inte tillhandahålla medicinerna för den behövande befolkningen då medicinerna är patentskyddade. Patentskydd regleras i TRIPS som även innehåller en del undantag till patentskyddet (ensamrätten). Exempel på undantag i TRIPS för u-länder att tillgå är parallellimport och tvångslicensiering. Ingen av nämnda undantag har hittills visat sig effektivt eftersom det råder oklarheter till vilken grad TRIPS regler om undantag är tillämpliga samt att u-länderna saknar både den kunskap och ekonomin som krävs för att kunna nyttja tvångslicenser. Försök har gjorts att utöka och klargöra TRIPS undantag från patentskyddet så att patentskydd för mediciner och rätten till hälsa kan samexistera utan den konflikt som råder idag.

Försöken till samexistens mellan patentskydd för essentiella mediciner och rätten till hälsa påbörjades genom DOHA konferensens erkännande av u-ländernas behov av hjälp. DOHA gav WTO uppdraget att inkomma med lösningar till konflikten mellan patentskydd i TRIPS och rätten till hälsa. Förslaget tillkom genom WTO: s Generalråd som år 2005 inkom med ett beslut som förtydligade bestämmelserna om undantag till patentskyddet i TRIPS. WTO: s Generalråds beslut har dock än idag inte blivit accepterat av medlemsländerna varpå beslutet inte kommit i kraft.

Vidare kan inte rätten till hälsa och patentskydd bli förenliga så länge de frihandelsavtal som finns mellan i-länder och u-länder innehåller regler som utökar patentskyddet utöver det som står i TRIPS, så kallade TRIPS plus regler. Frihandelsavtalen stadgar nämligen inte sällan restriktioner för tvångslicensiering och parallellimport utöver de som stadgas i TRIPS. Sammanfattningsvis kan sägas att frihandelsavtalen urholkar u-ländernas möjlighet att få access till essentiella mediciner och ökar klyftan till förening mellan patentskydd och rätten till hälsa.

Istället ligger vägen till ett närmande mellan patentskydd för mediciner och rätten till hälsa i att medlemsländerna godkänner Generalrådets beslut för utökning och klargörande av undantagen till ensamrätten i TRIPS. Samtidigt torde ett fortsatt engagemang av de institutioner som främjar utökningen av mänskliga rättigheter på WTO konferenser leda till en utökning av regleringar för rätten till hälsa inom WTO.

Slutligen vore ett förbud mot TRIPS plus klausuler i frihandelsavtal samt omförhandlingar av de befintliga frihandelsavtalen som stadgar TRIPS plus en väg som skulle möjliggöra en förening mellan patentskydd och rätten till hälsa. Det hela skulle underlättas om Generalrådsbeslutet godkändes av 2/3 av medlemsländerna.
Den nya tidsfristen är satt till den 31 december 2015. I det fall Generalrådsbeslutet då accepteras av 2/3 av medlemsländerna skulle detta leda till införandet av art. 31 bis TRIPS. Med tiden torde ett införande av art. 31 bis leda till att flexibiliteten i TRIPS ytterligare kan utvecklas. Vi kanske då även skulle få se hur förändringarna genom art. 31 bis TRIPS tagits emot av konventionsstaterna och världssamfundet över tid. I det fall medlemsländerna inte accepterar Generalrådsbeslutet kan tidsfristen än en gång komma att förlängas. Den 31 december 2015 torde därför vara ett viktigt datum att hålla i åtanke när det handlar om ett närmande till förening mellan patentskydd och rätten till hälsa. (Less)
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author
Larenas, Christian LU
supervisor
organization
alternative title
The Right to Health and Access to Patented Medicines
course
JURM01 20151
year
type
H3 - Professional qualifications (4 Years - )
subject
keywords
immaterialrätt, folkrätt
language
Swedish
id
7449614
date added to LUP
2015-06-25 14:52:16
date last changed
2015-06-25 14:52:16
@misc{7449614,
  abstract     = {At the moment of writing approximately two billion people around the world lacks adequate access to essential medicines. Furthermore approximately forty thousand people dies every day because of lack of access to essential medications. Mostly the affected populations are located in the developing countries. The availability of essential drugs has thus become a weapon to fight diseases affecting humans in developing countries. The right to health is declared in Universal Declaration of Human Rights (UDHR) and précised in CESCR. According to CESCR the right to health shall be achieved by the States parties through a progressively requirement. However, there is no judicial enforcement for the State parties not fulfilling the requirements in CESCR. Furthermore, the wording of the progressivity requirement in CESCR is vague and the determination on how the progressivity requirement is to be interpreted is left to the States parties to decide. The result ought being that the right to health declared in CESCR results in an obligation for the States parties to achieve the highest possible right to health for its citizens.

There is a conflict in international law between the regulations for patent protection for medicines and the regulations stipulating the right to health. Developing countries cannot afford to pay for essential medication to the pharmaceutical companies that mostly also are the patent owners. Patent protection is regulated in TRIPS which also contains exceptions to the exclusiveness of the patent right. Examples of exceptions for developing countries to the exclusiveness of patents are mainly the regulations in TRIPS for parallel imports and compulsory licensing. None of the exceptions has so far been proved to be effective as it is unclear to what extent the TRIPS regulations covering the exemptions for patent protection do apply. Furthermore the developing countries lacks the knowledge and have not the economic resources required in order to utilize the compulsory licenses. Nevertheless, attempts have been made to expand and clarify the TRIPS exemptions in an effort to reach for coexistence between patent protection and access to essential medications. Additionally an efforts to coexistence was initiated via the Doha Conference recognizing the developing countries' need for assistance. The outcome of the DOHA conference was that art. 6 DOHA gave the TRIPS Council the mandate to submit solutions to the conflict between TRIPS and the right to health. This was done by WTO via the General Decisions from year 2005. The WTO´s General Council decision has however still not been accepted by the States parties on which the decision still today is not into force. Moreover the right to health and patent law seems not being compatible as long as free trade agreements between developed and developing countries contains rules extending the patent protection beyond what is stipulated in TRIPS, also known as TRIPS plus rules. The free trade agreements also often stipulates restrictions on compulsory licensing and parallel imports beyond TRIPS regulations. 

The free trade agreements weakens the ability of developing countries to gain access to essential medicines and are also increasing the approximation between the patent protection in TRIPS and the right to health in international treaties.
The way forward for decreasing the gap between patent protection and the right to health could be realised if the State parties approved the General Council Decision with its increased flexibilities for TRIPS. Furthermore, the continuing involvement of the human right institutions that promotes the expansion of human right provisions at the WTO conferences is also a vital requirement for an extension of human rights regulations into the WTO regulations. A WTO treaty proclaiming human rights would be an optimal way of proceeding heading towards a balance between the regulations. 

Finally, the possibility for coexistence between patent protection and the right to health is in the prevention of the TRIPS plus clauses in the free trade agreements. Also the re-negotiation of the existing free trade agreements stipulating TRIPS plus rules would be beneficial for the co-existence. It would indeed also help if the General Councils decision was approved by 2/3 of the States parties. The new deadline for decision making is set for 31 December 2015. In case the General Councils decision is accepted by 2/3 of the State parties it might give us the possibility to know more about the effects of the suggested art. 31 bis TRIPS. The acceptance of the decision might in time also indicate how the flexibilities in TRIPS can be further developed and also how the effects of the changes are recognised by the State parties and the international community. In case the State parties once again doesn’t accept the General Councils decision, the timeframe for acceptance may be extended by the UN General Council. With that being said, 31 December 2015 could therefore be an important date to keep in mind with regard to patent protection and right to health’s potential co-existence.},
  author       = {Larenas, Christian},
  keyword      = {immaterialrätt,folkrätt},
  language     = {swe},
  note         = {Student Paper},
  title        = {Rätten till hälsa och tillgång till patenterade läkemedel},
  year         = {2015},
}