Rätten till hälsa och tillgång till patenterade läkemedel

Sammanfattning: 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.