Fecha: Jue, 21 de Ago, 2008 10:43 am
Asunto: Trasnacionales Farmacéuticas presionan por "TLC plus" en la reglamentación
Nota de Prensa
Trasnacionales Farmacéuticas presionan por "TLC plus" en la reglamentación
Lobbys de las trasnacionales farmacéuticas buscan influir la reglamentación de los Decretos Legislativos del TLC. Promueven estándares más altos de protección de datos de prueba que los aceptados en el TLC con EE.UU.
Se retrasaría aún más el ingreso de medicamentos genéricos al mercado.
Organizaciones sociales exigen participar en la vigilancia de la reglamentación.
Lima, 19/08/08.- El prestigioso informativo Inside US Trade de los EE.UU., alertó la semana pasada sobre las presiones que la gran industria farmacéutica estadounidense estaría haciendo sobre el Departamento de Comercio (USTR) acerca de los contenidos de los Decretos Legislativos que el Perú ha dictado para implementar el Tratado de Libre Comercio con Estados Unidos en materia de productos farmacéuticos. Estas presiones estarían orientadas a conseguir mayores estándares de protección.
Frente a esto, El Director de Acción Internacional para la Salud, Roberto López Linares, manifestó "es inaceptable este intento para que el Perú ajuste su normativa y reglamentos, yendo más allá del TLC para satisfacer los intereses de la gran industria farmacéutica, afectando el acceso a medicamentos de la población".
Frente a esto, El Director de Acción Internacional para la Salud, Roberto López Linares, manifestó "es inaceptable este intento para que el Perú ajuste su normativa y reglamentos, yendo más allá del TLC para satisfacer los intereses de la gran industria farmacéutica, afectando el acceso a medicamentos de la población".
Las trasnacionales farmacéuticas estarían buscando imponer una interpretación restrictiva del TLC, limitando el alcance del DL 1072. Son temas de preocupación:
a. Rechazo a la aplicación de la bioequivalencia: No aceptan que, en caso que un medicamento goce de protección y uso exclusivo de datos de prueba, los fabricantes de productos genéricos puedan obtener el permiso de comercialización con la presentación de pruebas de bioequivalencia. De otra manera los competidores tendrían que obtener sus propios "datos de prueba" o esperar "normalmente cinco años" para solicitar el registro de su producto.
b. Limites a la autoridad sanitaria: Rechaza que la autoridad sanitaria peruana tenga la facultad para decidir el tiempo de protección de datos de prueba en base a la "naturaleza" de los datos y la demostración de "esfuerzo considerable" para obtenerlos. La gran industria interpreta el texto del TLC que dice "normalmente por cinco años" como "por lo menos cinco años" y no acepta la posibilidad que la protección sean por menos de cinco años.
Finalmente, López comentó que diversas organizaciones e instituciones exigirán al Ejecutivo que se faciliten espacios de participación y vigilancia ciudadana ante el proceso de reglamentación del TLC, "Esta es la única forma de garantizar que el gobierno no se deje presionar por las grandes empresas, yendo en contra de la renegociación obtenida por los demócratas e imponiendo precios que con frecuencia son prohibitivos".
Agradecemos su difusión
ACCION INTERNACIONAL PARA LA SALUD, AIS
RED GLOBALIZACION CON EQUIDAD, RedGE
FORO DE LA SOCIEDAD CIVIL EN SALUD, ForoSalud
Contactos: Roberto López / Miriam Egúsquiza, AIS.
Teléfonos: 511 (3461502)
Artículo Original Adjunto
Inside US Trade
Peru Faces Complaints Over FTA Implementation On Drugs, Logging
Inside US Trade
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Peru Faces Complaints Over FTA Implementation On Drugs, Logging
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Date: August 15, 2008
Peru's decrees implementing its obligations under the free trade agreement signed with the United States have stirred up opposition from some U.S. stakeholders over intellectual property rights and other issues, including the penalties for illegally logging Peruvian forests, according to private-sector sources.
Pharmaceutical companies represented by the Pharmaceutical Research and Manufacturers of America (PhRMA) have raised complaints with the U.S. government about Peru's efforts to implement the FTA's data exclusivity provisions as well as the link between drug marketing approval and patent status.
The Office of the U.S. Trade Representative plans to raise implementation issues with the Peruvian government in a meeting scheduled for September, sources said. Peru and the U.S. had hoped to certify implementation of the FTA by November, when President Bush will attend the Asia-Pacific Economic Cooperation (APEC) leaders' meeting in Lima, Peru. But one private-sector source said there are indications the implementation process could take until March.
The U.S. drug companies have raised questions about the extent of the protection that Peru plans to give to brand name manufacturers' data showing the safety and efficacy of drugs, which is related to the speed with which generic drugs can get marketing approval.
Also, they have raised questions about Peru's willingness to provide new procedures ensuring that makers of brand-name drugs can resolve disputes quickly over patent infringement before generics hit the market, according to these sources.
Under the FTA, a patent holder has to have sufficient time and opportunity to enforce patent rights prior to the granting of marketing approval to a generic drug, according to a Democratic fact sheet detailing FTA changes announced on May 10, 2007, by the Bush administration and the House Democratic leadership.
An NGO source following the access to generic drugs said congressional Democrats had told NGOs that they would make sure the U.S. administration did not pressure Peru to exceed the requirements of the FTA. The source expressed alarm that U.S. firms and USTR could now be doing that.
The May 10 agreement requires procedures and remedies, such as judicial or administrative proceedings and preliminary injunctions, or equivalent steps for expeditiously adjudicating any dispute over patent infringement on a product that is pending for marketing approval, according to the fact sheet.
These procedures are meant as an alternative to the direct patent linkage provisions that were eliminated in the FTA, according to which a drug approval regulatory agency had to withhold approval of a generic drug until it was found to not infringe on a patent. As a result of these changes, PhRMA did not support the passage of the FTA but did not actively oppose it either.
The relevant Peruvian decree does not lay out these speedy procedures, and seeking a remedy under the existing Peruvian rules is not quick enough to prevent an infringing drug from entering the market, according to a pharmaceutical industry source.
Copyright industries are still examining the decrees, and are planning to submit any objections to the decrees they may have on copyright and on border measures for consideration in the U.S.-Peru September meeting, according to a private-sector source
Drug companies want to ensure that any of the issues left ambiguous by the presidential decrees passed in June will be addressed in the implementing regulations, according to a private-sector source. This will take time, and some drug company representatives fear the administration may race to complete the implementation process by November, when Bush is scheduled to attend the APEC summit.
On data exclusivity, pharmaceutical companies are alarmed over a provision that would allow Peruvian authorities to approve a drug solely based on a producer's proof that it has bioequivalence to one already marketed in Peru, a private-sector source said. Bioequivalence means the drug has essentially the same chemical composition, he said.
Granting marketing approval on the basis of bioequivalence would make the FTA's data protection provisions "essentially meaningless," he charged. If a producer only needs to prove bioequivalence of a given drug, there would be no need to provide test data proving its safety and efficacy, according to the industry source.
Reliance on test data has the effect of slowing the entry of generic drugs into the market, because the FTA stipulates that generic manufacturers normally have to wait five years before they gain access to brand-name manufacturers' undisclosed test data.
Alternatively, generic manufacturers could generate their own test data showing the safety and efficacy of a given drug, which they generally do not do because of the cost.
Under the FTA, there would normally be a five-year period of data exclusivity. This would run concurrent in Peru to the time that a drug was first approved in the United States, if Peruvian authorities rely on a marketing approval by the Food and Drug Administration and allow the sale of the drug within six months of an application, according to the Democratic fact sheet on the May 10, 2007, agreement.
In a second complaint about Peru's implementation of the FTA's data exclusivity provisions, pharmaceutical companies question whether Peru plans to provide five-years of protection as a rule, or will determine it on an ad hoc basis, according to an industry source.
In the U.S., five years are the norm for new chemical entities, but if a drug approved for one purpose is found to have additional applications, the FDA provides three additional years of data exclusivity, the industry source said.
The pharmaceutical companies' fears stem from the decree's wording that five years of data exclusivity are provided for test data that required "considerable effort" to generate and that Peru would seek to define that term on an ad hoc basis. The text does not define what the term "considerable effort" means, according to a copy of Decree 1072.
This could mean Peru plans to implement data exclusivity on an ad hoc basis, with lesser effort leading to a shorter term of protection, the industry source said. This would inject an element of uncertainty into the data exclusivity provisions, he said.
If Peru attempted to define "considerable effort," Peruvian authorities may also seek information from drug companies about how much money they spent on generating the given test data, and then link that level of expenditure to the length of the data exclusivity period. This could also mean that Peruvian authorities would seek proprietary business information in that process, he said.
As a rule, the term "considerable effort" is not defined in FTAs because it reflects a term used in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), he said.
In a related development, the Community of Andean Nations on Aug. 14 granted Peru the right to amend its intellectual property rights laws over the objection of Bolivia. Peru had sought the support of Colombia and Ecuador to make the changes and with Ecuador's support, the changes passed by a vote of three to one.
On illegal logging, the Peruvian Congress has yet to amend the penal code to apply prison sentences for individuals convicted to illegally cutting forest. The provision is controversial within the Peruvian Congress, sources said, because some members argued that many impoverished Peruvians would be sent to jail by the law.
The draft legislation gave jail sentences for small-scale tree cutting, such as for firewood, as well as for large-scale logging. Under the FTA, Peru must combat illegal logging "consistent with" the requirements of the Convention on International Trade in Endangered Species (CITES).
An informed source said that the standing committee of CITES failed to promote Peru to Category 1 under its National Legislation Project at the July 14 annual meeting of its standing committee. A CITES official visiting Peru in June had said he found a lack of sufficient criminal penalties, this source said.
USTR has interpreted elevation to Category 1 as meeting the requirements of the FTA, and the standing committee will not meet again until next summer. One source speculated that the permanent CITES secretariat could declare Peru as meeting the requirements of Category 1 without actually elevating Peru, a task of the standing committee. USTR could then deem this to constitute compliance with the FTA.
Indigenous people protested the forestry law this week and temporarily shut down a natural gas field in Peru, but sources said that the regulations implementing the forestry law as well as the overall FTA process will not be delayed by protests at Camisea Block 56.
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Miriam Egusquiza
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