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Malaysia – Implementation Of Data Exclusivity(DE)

The National Pharmaceutical Control Bureau (NPCB) in Malaysia ensures the quality, efficacy and safety of pharmaceuticals through the evaluation of technical data and laboratory test conducted during clinical trial. Upon fulfilment of all safety regulations, approval is given for marketing.

Malaysia is a member of World Trade Organization (WTO). Under Article 39.3 of the TRIPs Agreement, members are required, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilise new chemical entities, to submit undisclosed test or other data, generated through considerable effort and cost. Such data shall be protected against unfair commercial use because, given the heavy investment to conduct clinical trials, exclusivity over the data generated must be protected.

The term data exclusivity is now very well known.  It basically means that the data submitted to regulatory bodies (like NPCB in Malaysia) for approval of a marketing authorisation must belong exclusively to the originator and a third party; typically a generic-drug producing company cannot have the same access to the original data submitted by the originator even though the product is bio-equivalent (pharmaceutically similar in terms of intent and purpose). To comply with the Article 39.3 of TRIPs, NPCB has implemented data exclusivity effective from March 1 2011 for undisclosed, unpublished and non-public domain pharmaceutical test data and the term is five years for a new chemical entity and three years for a second indication. Legally, data exclusivity will prohibit generic companies from relying on the trial data submitted by the originator. It is worth mentioning here that the United States and European Convention (EC) countries grant a data exclusivity period of five years (in the US) and  six to 10 years from the first marketing of the product, or of six years maximum dependant on the term of patent protection of the relevant product (in the EC).

However, it has to be mentioned here that under the data exclusivity directive in Malaysia, there is a clause stating that exclusivity shall not apply to situations where compulsory licences has been issued or in cases to protect public health. In retrospective, compulsory licensing is an exception to the main principle of exclusivity – if compulsory licensing is approved, a company can bypass any patent or data exclusivity already issued. The reason for the exemption clause is to provide an affordable medical solution to society at large where appropriate.