The Ecuadorian government has signed a trade agreement with the European Union to increase medicine patent protections.
IHS Life Sciences perspective | |
Significance | Ecuador has agreed to protect data exclusivity for a minimum of five years, starting in seven years' time. |
Implications | The Association of Pharmaceutical Laboratories in Ecuador has voiced concerns over a new regulation, arguing that the data exclusivity protection is an extension of the 20-year patent protection. |
Outlook | The intellectual property regulation of the trade agreement will benefit the international pharma companies present on the Ecuadorian market, but could negatively affect generics' access to the market. |
A trade agreement signed between Ecuador and the European Union will extend protection for innovative pharmaceutical products in the Ecuadorian market, reports news agency EFE and several Ecuadorian newspapers. According to the sources, intellectual property (IP) was one of the most difficult aspects to agree on during the negotiations, and it has caused a big controversy in Ecuador.
Regarding the pharmaceutical IP aspects of the agreement, Ecuador has agreed to protect test data exclusivity for a period of a minimum of five years. Clinical trial data exclusivity is an additional protection given to the producers of new pharmaceutical products to protect the data used during clinical trials, which is required to be submitted to a regulatory agency to prove safety and efficacy of a new drug. According to Ecuador's minister of foreign trade, Francisco Rivadeneira, the data exclusively protection will be put in place in seven years, and in the mean time the government will introduce the internal legal instruments to incorporate the new agreement in the Ecuadorian legal system.
Although Rivadeneira stated that the agreed regulation will not affect the local industry, the president of the Association of Pharmaceutical Laboratories in Ecuador (ALFE), Renato Carló, has expressed opposition to the new regulation, arguing that the five-year data exclusivity protection is an extension of the 20 years of patent protection already provided by the Ecuadorian IP system and that it will negatively affect local industry. Additionally, in an interview with Ecuadorian newspaper El Telégrafo, Carló has highlighted that the local pharma industry was never consulted regarding the IP aspects of the trade agreement during the negotiations.
Outlook and implications
According to Carló, the national pharma industry must restructure and improve generics access to the market in order to ensure strong local generics production before the agreement commences in seven years. Ecuador has been developing a strong local industry that produces generics in order to provide competition and reduce medicine prices once patent protection has expired. The new five-year data exclusivity protection period will benefit the international pharma companies in Ecuador's market, but generics access into the market could be affected. For the European pharma industry that supplies innovative medicines to the Ecuadorian market, the trade agreement will provide an additional protection for them, and it would represent an opportunity for the companies to improve their international revenues. The new agreement is expected to be welcomed by the international companies based in Ecuador, as generating clinical trials and marketing authorisation data are normally the result of a number of trials and a large amount of clinical research, which represent high cost for the companies.
It seems strange that the Ecuadorian government has agreed to increase the protection for innovative medicines through a trade agreement, considering the fact that the Ecuadorian Institute of Intellectual Property (Instituto Ecuatoriano de la Propiedad Intelectual: IEPI) has issued compulsory licences for nine innovative drugs during the last year in order to reduce medicine prices (see Ecuador: 30 July 2014: Ecuadorian Intellectual Property Institute announces savings from compulsory licences for nine drugs). However, it is important to highlight that granting additional IP protections through trade agreements is a continuing trend in Latin America, as Peru and Colombia have achieved similar agreements with the EU and the United States (see Peru: 22 May 2014: TPP could affect access to generic medicines in Peru).