Despite numerous rounds, the US and Malaysia continue to have ongoing negotiations over the regulations of drugs and patents under a future Free Trade Agreement. The deadline for fast-track approval has passed, and resolutions to patents and generics regulations are not forthcoming.
For generics, the main issue is data exclusivity. Currently, under the WTO’s regulations, drug manufacturers are allowed 20 years’ patent protection on their drug products. However, there have been proposals to include data exclusivity under the US and Malaysia’s future Free Trade Agreement. This data exclusivity would require generic companies to conduct their own clinical trials, which are time consuming and often too costly for generic companies. In addition, governments would not be able to cite clinical test data when considering marketing approval for a generic product.
In Malaysia, marketing approval only requires proof of bioequivalence between the generic and original product. Since the government has access to proprietary clinical test data, it can easily determine this bioequivalence without requiring the generic company to conduct its own clinical trials.
There has also been discussion on extending patents to account for unanticipated delays in marketing approval period or during the patent review process.