COSTA RICA

On November 3, deputies Welmer Ramos Gonzalez, Luis Ramon Carranza and Mario Castillo (members of the PAC – ruling party), presented the bill to Promote Competition in the Drug Market. The initiative seeks to guarantee people’s access to medicines in the private sector, including oncological medicines such as trastuzumab. It also includes provisions on price regulation and advertising. The bill does not yet have a committee assigned to it. In order to initiate its discussion under the current extraordinary session of the Legislative Assembly, the Executive Branch must include it in its list of called bills, something that has not yet happened.

According to the text, the law would reach manufacturing laboratories, drugstores and pharmacies of the private sector. Thus, it prohibits contracts or exclusivity clauses between laboratories and drugstores, as well as drugstores denying the sale of drugs to pharmacies that require supply. It also mentions that laboratories, drugstores and drugs registered in any country that has a Strict Regulatory Authority or a Regional or Level IV Reference Regulatory Authority of the World Health Organization or the Pan American Health Organization will be considered as registered before the Ministry of Health with the sole request for registration.

Regarding market regulation, the Ministry of Economy (MEIC in Spanish) will be in charge of supervising this market. To this end, the Ministry will have to carry out studies to determine, among other things, the need or not to regulate the price of medicines. All medicines on sale in the private sector that are part of the same therapeutic group as the medicines included in the basic drug list of the Costa Rican Social Security Fund (CCSS in Spanish) will be subject to possible regulation. The initiative also mentions the criteria that the MEIC will consider to determine price intervention.