Elmer Torres Cortes is General Manager of the Industrial Association of Pharmaceutical Laboratories (ASILFA) that was created to defend the interests of the generic and local manufacturers. Cortes speaks about the developments of the Chilean pharmaceutical industry.
What are the main drivers and challenges for the Chilean pharmaceutical industry today?
Our industry has high expectations for the future. ASILFA’s members have invested in their plants and adopted international standards for good manufacturing practices (GMP). The pharmaceutical industry is in constant innovation and a strategic pillar for the Chilean economy
Today, thanks to the new ley de fármacos there are more opportunities for growth to offer better quality bioequivalent products to our community and to the nearby regions. Chile’s pharmaceutical industry is very well seen by our neighboring countries, this has created some very positive expectations regarding the impact that the new ley de fármacos and our mission with bioequivalent and generic drugs will have on the industry.
The distribution channels for pharmaceutical products are controlled mostly by the three major pharmacy chains in the country. Two of these pharmacies were fined USD 19 million each; the heaviest penalties it’s ever imposed for price-fixing. How has this impacted business for your members?
Undoubtedly, Chile’s situation on this example is exceptional: this is probably the only country that distributes medicines through three pharmaceutical chains, which between them control 94 percent of the retail market.
The situation has not affected the ASILFA members. What happened is something exclusive to the pharmacy chains, and it is only them that have to demonstrate that they were responsible for the commercial management of a significant number of medications that undoubtedly impacted the population.
ASILFA, as an association does not have any inference on this commercial issue. Our objectives are not commercial, which is why I can’t give you a commercial opinion regarding something that is outside of ASILFA’s jurisdiction.
Chile was the first country in Latin America to have a Pharmaceutical Patent Law. Chile signed the TRIPS agreement that regulates intellectual property with 140 countries in the WTO. In addition Chile signed numerous free trade agreements with for example the US. How are the members of ASILFA dealing with such claims?
Chile has respected international norms. To date, I believe that Chile has respected all international agreements, especially patent agreements.
What tends to happen in the industry is that there are different views regarding this topic. We have a different outlook when compared to the Americans or even the international perspective. In Chile, we register in Chile well over four thousand new patents. However 80 percent of these applications are rejected by the authority on the grounds that the patents already completed their cycle.
Chile currently has a free-trade agreement with the USA. Obviously an agreement was reached regarding all of the regulatory practices for patents between both countries.
What will be the impact of the recently appointed government?
We believe this is a positive development. We are familiar with newly elected President Bachelet’s, who is a doctor by profession, and her outlook on the industry. We effectively believe that the new Medicine Law will be propelled during this government in order to ensure access to medicines for all Chileans including the most vulnerable groups.
In addition we are pleased with the appointment of Helia Molina the new Minister of Health. I have had the pleasure working with her when I was the president of Colegio Farmaceutico. At the time we had a couple of meetings about certain technical aspects. I believe the new government will be very receptive to the needs of the industry.
What will the results be of ANAMED changing its board?
In addition to El Instituto de Salud Pública de Chile (ISP), the regulatory agency for the pharmaceutical industry, the industry needs an agency responsible for regulating medicines. The agency should reach level 4 of the Pan American Health Organization (PAHO) assessment table. Level 4 is the level that enables PAHO to designate the regulatory body as a reference authority for medicines and biologicals. Moreover the agency should be autonomous and independent and capable of monitoring the local and international industry.
Currently in parliament a proposal is being discussed regarding this matter. We contributed with our knowledge and expertise on the technical aspects required for the creation of a good agency. The Department of Studies from the “Facultad de Derecho” from the Universidad de Chile was hired to conduct a research on what would be the best model to create this agency in the country.
This was in fact our initiative. After we conducted the study we submitted it to the government to consider it. I believe some aspects of the research are being taken into account. The proposal is discussed in parliament and we hope it will be approved as soon as possible. Hopefully, in 2014 we will have an independent agency in charge of supervising all imports and exports for the country. We believe this is fundamental for the pharmaceutical industry in Chile.
How has the cooperation between the main associations in Chile, the CIF and ASILFA evolved over the years?
We have a good relationship with them; a very professional relationship. We are working in tandem and the top executives of both entities are participating in meetings together. As an example we collaborate on discussion in regards to the new Medicine Law. Overall, I would say that we have a good relationship.
How would you describe the quality level of the scientists and technicians available here in Chile for the industry?
As Chile is a relatively small county we do not have a large number of scientists. But the scientists we do have in the industry have a very high level. They deserve all of our respect and trust. Some of them have received numerous awards; they have created vaccines on an international level. We don’t have quantity but we certainly have quality.
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