New Trade Agreement Would Boost Generic Drug Access
A proposed new trade policy with Columbia, Panama and Peru strikes a balance between protecting innovation and providing access to affordable generic medicines abroad, according to the generic drug industry.
The bipartisan agreement, announced in May after months of negotiations between the House Ways and Means Committee and the White House, would change pending free trade agreements (FTAs) with these countries to promote drug access, among other provisions.
Under the new policy, generic drugs would be able to enter the market more quickly in these countries due to changes to rules on data exclusivity, patent extensions and drug approvals.
Another change involves patent extensions. Currently, regulatory agencies are required to extend a drug’s patent term to compensate for delays in the approval process. Such an extension would be optional under the new policy, and the U.S. would assist foreign regulators in speeding the drug-approval process.
In addition, pending FTAs would be amended to eliminate the requirement that a regulatory agency withhold approval of a generic drug until it can prove no patents would be violated. Instead, the U.S. would help strengthen the process of resolving patent disputes.
The policy also calls for a so-called side letter included in current FTAs to be added to the main text of pending FTAs. The letter affirms the U.S.’ commitment to the Trade-Related Aspects of Intellectual Property Rights Agreement, which includes countries’ right to grant compulsory licenses in the interest of public health.
According to the version of the agreement drafted by the Office of the U.S. Trade Representative, while the policy would offer more flexibility with respect to drug access, there would still be ample IP protections for brand companies, including:
- Rules against the unfair use of clinical trial data;
- Procedures to keep patent-infringing products off the market;
- Efforts to ensure that approvals and patents are granted quickly; and
- Policies to combat counterfeit drugs.
The trade agreement is available at waysandmeans.house.gov/Media/pdf/110/05%2014%2007/05%2014%2007.pdf.
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