The Trans-Pacific Partnership (TPP) announced this week that promises to reduce the cost of manufactured goods and agricultural products to consumers, improving labor and environment protection, and strengthen rules against counterfeiting and intellectual property theft. But experts say that some aspects of the agreement signed by the United States and 11 other Pacific Rim countries representing two-fifths of the world economy, could affect public health.
A major concern is the intellectual property (IP) rights for drugs. Pharmaceutical companies have lobbied for better protection for organic products: products derived from organisms that are a hot area of R & D living. The United States provides the most favorable conditions for data exclusivity, which keeps vital information on medicines on the hands of generics. With organic products, "to [make drugs] safe for the consumer" Generic manufacturers need access to information on drug manufacturing, said Tim Mackey, an analyst of global health policy at the University of California , San Diego. If the makers of "biosimilars" -the general term biological-do not have access, "they may give up."
The United States currently gives drug companies 12 years of exclusivity before biosimilars manufacturers can access their data for new submissions to the Food and Drug Administration (FDA). TPP partners Australia and Chile offer 5 years of exclusivity, and others not at all. "Most countries in the world have zero data exclusivity; This is a new monopoly of data that does not exist in many national laws, "said Judit Rius Sanjuan, a legal policy advisor for Doctors Without Borders (MSF), which opposes the intellectual property protections of the Agreement.
The US was pushing to 8 years of protection. As a compromise, all parts of the PPT have agreed to provide at least 5 years of data exclusivity. (The United States retain 12 years.) The Agreement "below the most extreme demands of Big Pharma but contribute to the suffering and death preventable," said Peter Maybarduk, a group leader Public Citizen consumer advocacy in Washington, DC This is not how drugmakers see. "We are disappointed that the ministers failed to get 12 years of data protection for biological drugs," said the Pharmaceutical Research and President American John Castellani manufacturers in a statement. "The ministers missed the opportunity to encourage innovation that will lead to the most important rescue drugs that would improve the lives of patients. "
But pharmaceutical companies may have won rights additional patent. the details are not yet clear, the TPP wording has not yet been made public. But Brook Baker, Professor of law at Northeastern University in Boston, said the deal probably includes provisions for extensions patent term to compensate for delays and patenting new regulatory practices and patent known drugs. "with the protections of higher intellectual property obtained in the TPP, it will be more difficult for developing member countries to develop their own capacity local, "says Baker, who is on the board of the global Health Access Project, which advocates for people living with HIV / AIDS.
last spring, a team of Australian experts and public health in the United States examined the potential impact of the provisions in Vietnam in a project leakage of the TPP agreement. As they reported online in April, according to this version of the TPP the cost of treating a person infected with HIV in Vietnam could rise from $ 304 to $ 501 per year. Given tight budget of the country, that the increased cost could reduce HIV treatment rate in Vietnam from 68% to 30%, leaving more than 45,000 rescue treatment of people every year, they argued. Study co-author Brigitte Tenni, a public health consultant at the University of Melbourne in Australia, said the team can not determine to what extent their analysis is still valid because they have not seen the final agreement. But "any increase in the protection of intellectual property is held to have devastating consequences for access to medicines in particular for people living in developing countries like Vietnam," she says.
the TPP offers a partial victory for the tobacco control efforts. tobacco companies have used clauses in trade agreements known as settlement investor-state dispute (ISDS) provisions to initiate arbitration on plain packaging laws they say deprive their brand benefits. After losing a court battle against the law of plain packaging in Australia, Philip Morris Asia Limited relied on a provision of ISDS in a 1993 agreement between the Australia and Hong Kong to launch arbitration. a provision TPP called "a Party may choose to deny the benefits of investor-state dispute regarding settlement of a claim challenging a measure against the Party of smoking," according to the US trade representative's website. The organization Control in the US Action on Smoking and Health called the provision a "great victory for public health."
But "the devil is in the details," said Sharon Friel , a public health expert at the Australian National University in Canberra. Without examining the language of the agreement, she said, "it's hard to say exactly what is possible." She thinks that the tobacco companies could still drop ISDS claims, leading in some cases to a "regulatory chill" or unwillingness on the part of governments to adopt tobacco control measures that could invite costly litigation. Australian newspapers have recently reported that the country has accumulated AU $ 50 million ($ 36 million) in legal fees in its dispute with Philip Morris. Avoid such a confrontation, "is of course much more likely to occur in poor countries, where smoking is on the rise and therefore the risk to public health," said Friel. She added that tobacco companies will still be able to use the provisions of ISDS in other trade agreements, such as Philip Morris's use.
TPP ultimate fate is decided. in many countries, including the United STATES, governments must get approval from their legislatures.
0 Komentar