Matrix 公司获得预期的FDA“未批准”信函(下)
The declaration would also clarify that those countries that do have their own generic manufacturing capacity are permitted to override patents though compulsory licensing in order to produce copies of drugs when necessary. Nothing in the present TRIPS agreement prohibits that practice, but the declaration would ensure "clear political support to use the safeguards that exist within the agreement as widely as possible," Doctors Without Borders' Ellen 't Hoen said.
"Really, there isn't such a thing as one single agreed upon interpretation of these safeguards," she pointed out. The declaration would "provide interpretations--particularly with regard to the exports issue--that are not provided at the moment in the TRIPS agreement."
The declaration, which has at its core the statement that nothing in the TRIPS agreement should prevent governments from protecting the health of their people, would not change the agreement itself, but could influence its interpretation. "The United States actually is trying to limit the power of this declaration by inserting language that would render the statement useless in dispute-settlement procedures...but, without that, this document would certainly play an important role in dispute-settlement procedures in the future," 't Hoen said.
US trade officials have expressed opposition to the declaration as it stands, saying that its wording could be stretched and manipulated to invalidate patents for trivial reasons. Instead, the US has proposed that the least-developed countries should be allowed a 10-year extension on complying with TRIPS rules on drug patents, giving them until 2016. In addition, it has suggested a 5-year moratorium on WTO challenges to poor sub-Saharan African countries over any actions related to fighting health crises caused by diseases like HIV/AIDS, malaria and tuberculous.
But with developing countries making up 80% of the WTO's membership, the US faces serious opposition. "We have an expression in the Netherlands for these kinds of proposals," 't Hoen said. "It is trying to make someone happy with a dead bird.", http://www.100md.com
"Really, there isn't such a thing as one single agreed upon interpretation of these safeguards," she pointed out. The declaration would "provide interpretations--particularly with regard to the exports issue--that are not provided at the moment in the TRIPS agreement."
The declaration, which has at its core the statement that nothing in the TRIPS agreement should prevent governments from protecting the health of their people, would not change the agreement itself, but could influence its interpretation. "The United States actually is trying to limit the power of this declaration by inserting language that would render the statement useless in dispute-settlement procedures...but, without that, this document would certainly play an important role in dispute-settlement procedures in the future," 't Hoen said.
US trade officials have expressed opposition to the declaration as it stands, saying that its wording could be stretched and manipulated to invalidate patents for trivial reasons. Instead, the US has proposed that the least-developed countries should be allowed a 10-year extension on complying with TRIPS rules on drug patents, giving them until 2016. In addition, it has suggested a 5-year moratorium on WTO challenges to poor sub-Saharan African countries over any actions related to fighting health crises caused by diseases like HIV/AIDS, malaria and tuberculous.
But with developing countries making up 80% of the WTO's membership, the US faces serious opposition. "We have an expression in the Netherlands for these kinds of proposals," 't Hoen said. "It is trying to make someone happy with a dead bird.", http://www.100md.com