On 19 March 2019, Senator Richard Aguilar filed a proposal to add an article to Bill No. 311 of 2019 (National Development Plan (NDP) 2018-2022), forcing pharmaceutical patent applicants to include the International Nonpropietary Name (INN) of the active ingredient determined by the World Health Organization (WHO). If there is no INN established for an active ingredient, the obligation is ongoing until one is established. Failure to comply with this obligation would generate fines of up to USD 1.5 million. This provision potentially violates Article 32 of Andean Decision 486 and the Andean General Provision against any internal regulation that is not absolutely necessary under the “complemento indispensable” principle (essential supplement).
Although this proposal was not included in the text approved during the first debate by the Joint Sessions of the Third and Fourth Committees of the House of Representatives and the Senate of the Republic, which was published in the Official Congressional Gazette No. 211 of 2019, it is possible to introduce amendments at any time during the legislative procedure.
The NDP was filed before Congress on 6 February 2019 and was published in the Congress Gazette on 7 February 2019. According to applicable law (Law 152 of 1994), Congress has 3 months starting from the publication to approve the NDP. Therefore, the final deadline for Congress to approve the NDP is 7 May 2019. If Congress fails to comply with the mentioned deadline, the President is entitled to approve the NDP through a Presidential Law-Decree.
