The main issue relating to patent protection and access to medicines is the data exclusivity clause. To bring a patented drug to market, a pharmaceutical company must demonstrate through clinical trials that the drug is both safe and effective. Under U.S. law, the data used to determine these claims are protected from use by generic drug manufacturers to certify their own products for a period of five years from the date the patented drug is allowed to be used in a country`s market. This protection refers to what is called the notion of data exclusion. Changes to the PTPA text on data exclusivity would give Peru the duration of data protection, which remains linked to the U.S. protection period, which could reduce the time it takes for generic drugs to be approved on the Peruvian market. The original text of the agreement would have delayed the availability of generic drugs on the Peruvian market by at least five years, even if the patent had already expired. In early 2007, several members of Congress stressed the need to strengthen PTPA requirements for the adoption of the agreement and said that basic ILO enforceable labour standards should be incorporated into the text of the agreement. In March 2007, the Democratic leadership of the House Ways and Means Committee announced a series of business principles (principles of democratic trade) 34 that “can pave the way for the restoration of a cross-party trade consensus.” 35 Among these principles was the obligation on the signatory countries of the free trade agreement to adopt basic ILO labour standards and to agree on provisions for the application of these standards in the agreements.36 Another factor to consider is the extent to which the PTPA would create trade beyond trade diversion.31 One of the drawbacks of a bilateral free trade agreement is that it can lead to trade diversion , because it does not fully cover all regional trading partners. Trade diversion leads a country to enter into a free trade agreement and then transfer the purchase of goods or services (imports) from a country that is not an EsTV partner to a country that is a free trade agreement but is still a high-cost producer. In the case of the United States and Peru, for example, products from the United States can replace cheaper imports from Peru from other Latin American countries. If that were to happen, the United States would now be the producer of this article, not because it produces the good more efficiently, but because it gets preferential access to the Peruvian market.
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