Dra. Cajigas, you were appointed Director General of INVIMA just over two years ago. What have been the biggest challenges that you have faced since the start of your tenure?
When I was appointed two years ago, the priority for INVIMA was the sanitary vigilance of food. We participated in a lot of studies in that field along with the Planning Department. In 2010, the government changed, and the new administration had different priorities, so one of my earliest tasks has been to readjust the agency to the new requirements.
At this time, the government wanted to strengthen vigilance on food but also on sanitary regulations in general. We lead a consultancy during 2011 along with different entities, agencies, and reference countries. INVIMA looked at the regulatory environment in the United States, Canada, Australia, Japan, and last but not least Brazil, who has certification from the Pan-American Health Organization. From that observation, INVIMA started restructuring its organization alongside with the Ministry of Agriculture, Ministry of Social Protection, the Ministry of Health and Social Protection, and the President of the Republic. In October 2012, the new organization and norms of INVIMA were approved. All the subjects concerning access to the markets and improvements of the competitiveness of Colombia will come later. During this year and a half, INVIMA improved much of the regulatory framework of the country.
The national system of vigilance is led by the Ministry of Health, but there are different entities with different missions. On one hand there is the National Health Institute (Instituto Nacional de Salud), led by Fernando de la Hoz, focused on epidemiologic vigilance, on the other hand INVIMA, focused on sanitary vigilance on consumer products in general. There is the Secretary of Health as well. Every entity is working under the Ministry of Health.
What have been your biggest milestones and achievements?
INVIMA multiplied human resources passing from 480 people, to more than 1000. Similarly, the agency’s 2012 budget was multiplied by three compared to 2009. Also, INVIMA does not receive public resources, and obtains financial resources from its operational activities. In 2013, INVIMA’s budget of COP 160 million it´s been very important.
Restructuring has been a long process. INVIMA’s main achievements have been the commitment to harbors and airports, from where products are coming. Before, INVIMA was only focused on food products, but the agency’s regulation has been extended to cosmetics, for example.
Secondly, INVIMA has worked on access to international markets. Normally this function is assumed by The Ministry of Commerce, Industry and Tourism but INVIMA has participated as well from the health point of view.
Historically, Colombia has enjoyed a strong presence of pharmaceutical companies. Why was a regulatory authority for food and drugs only created in the last twenty years in Colombia?
Colombia created a new healthcare system in 1993 with the noted Law 100. Before that, Colombia had a national system, entirely controlled by the government. However, this system was showing its limits: the health coverage rate for Colombians was only 17 percent. The Ministry of Health was essentially the regulatory actor at the time. The Law 100’s main objective was to reach universal coverage of the population. From Law 100, INVIMA was created.
What is your position with respect to the level of integration of the various vigilance agencies across Latin America? What does INVIMA have to learn from such agencies like COFEPRIS in Mexico, or ANVISA in Brazil?
INVIMA was certified in 2010 by the Pan-American Health Organization (PAHO). In Latin America, Brazil and Argentina were the first countries to do this. Then Cuba, Colombia, and Mexico followed. This positions INVIMA as a national regulatory authority within the international sanitary environment. ANVISA, the Brazilian agency, has an international scope and are well-known in Europe. With the other agencies, INIVMA agreed on different things: the agency signed different confidentiality clauses to have access to information on each other’s activities. Secondly, the various agencies are exchanging best practices. For example, nowadays, INVIMA is working to combine technology and sanitary inspection. Since Argentina has a good system in this regard, Colombia sends over people to be trained.
Similarly, the Argentinean agency has a system of very efficient laboratories, shared with third party actors like private companies. Currently, Colombia does not have the capacity for this, but the nation is trying to copy this model. INIVMA’s current strategy involves enlarging its partnerships. The “third actors” for INVIMA can be public and private national laboratories, and other certificate agencies. This process requires a lot of trust, and INVIMA is trying its hardest to improve standards.
Colombia is of course a country that is moving, with a growing population and a very dynamic economy. For the first time, INVIMA has the ability to participate in conferences involving different agencies from all over the world, from both developed and emerging countries, like the 7th Summit Heads of Medicines Regulatory Agencies. It allows INVIMA to advance in the same direction as agencies from developed countries. Additionally, the methods of the PAHO are different than similar organizations in Europe or Australia. I want to take the opportunity to learn from those references.
For example, INVIMA should take the ANVISA certificate and sign it. This requires training for INVIMA’s technicians and, in a way, a change in the agency’s general approach.
Colombia is generally one of the first countries for innovative products, but products from other countries, like India for example; often have difficulty trying to enter the Colombian system. How does INVIMA create a balance between strictness and availability?
I have to point out that INVIMA does not create the norms; they are created by the Ministry of Health and Social Protection. INVIMA only participates from the technical point of view. The agency can propose criteria, but it is the Ministry that approves them. INVIMA is trying to make the norm flexible, according to three standards: quality, efficiency and safety. Every laboratory has to meet those three conditions in order to receive INVIMA’s certification. It is quite simple: if the laboratories meet them, they are accepted; otherwise they are rejected. We cannot admit any laxity, because we regulations must be respected.
Colombia has been working on biotechnology regulations for more than six years (2 years in INVIMA, and four years before), and it is clearly a lengthy process. When you create a norm, you have to take into account those three criteria (quality, efficiency and safety), but also you have to consider access to the population. INVIMA is very committed into providing access to the Colombian population.
What is the potential of INVIMA not just as a quality controller, but also as a promoter of Colombian exports?
INVIMA participates in some programs alongside the Ministry of Commerce, Industry and Tourism and agencies such as ProExport. The agency is helping in that it can give equivalencies in terms of norms between different countries. For example, if Colombia wants to export meat to Russia, Colombian exporters have to meet Russian prerequisites. INVIMA is the link between what they have and what they need to fulfill. The agency is working in collaboration with other regulation agencies so that each can guarantee the certifications of others.
INVIMA does not work on promotion for exports as such. This field belongs to the business world. However, INVIMA does participate in helping those who want to export. The agency works with them, trains and advises, and audits their plants, helping them with the sanitary requirements of the import country.
Colombia serves as an excellent hub for clinical research, especially for the biotechnology industry. What effect will the third draft of clinical research reform, as proposed by Minister Gaviria, have on the biotech industry?
One of the responsibilities of INVIMA is approving the protocols of research. There is a group dedicated to this mission. The requirements tend to be very demanding. If, with the new reform coming, INVIMA has to approve clinical research, it will do it. Another mission is the vigilance and development of research from a sanitary point of view. We have a group of “clinical good practices” dedicated to studies and protocols, which are revised and approved by a committee of experts. Colombia has one of the largest investments in pharmaceutical R&D in the world. This country has a free price policy that makes its market very interesting for foreign investors.
You have 25 years of experience in the healthcare industry, both in the private and public sector. What are the main differences in management styles between the two?
There are many differences. But to me, the public sector does impact the country, whereas the private sector has a more limited impact. Another difference is that managing the private sector is much easier than the public one. In 2010, the Colombian health sector had 5500 norms! What matters in the private sector is the result, whereas the norm is the priority of the public sector. Last but not least, the timelines are much longer in the public sector compared to the private one.
If we were to return to Colombia in three to four years, what goals would you like INVIMA to have achieved by that point?
First of all, you will find us in a brand new building. The agency will move into its new headquarters in Bogotá in 2014-2015. Secondly, INVIMA will have an online information system so that the agency can offer total transparency to its customers. Being able to offer a service of public consultancy is main priority: having reliable information online, and being available for consultation at any moment. Users will be able to consult the rankings of all registered products. Today, INVIMA has high-skilled and experienced individuals, but wants more doctors. The agency has the ambition to attract new profiles. INVIMA wants to open new regional offices, as well as to be closer to Colombians, advising them both on food and drugs. In five years, INVIMA should have implemented a number of regulations, particularly with biotech, to such an extent that all stakeholders, international companies and agencies know what the rules of the game are. The Ministry of Health will help to build new norms. INVIMA also plans to strengthen a national network of laboratories and will invest many human and technological resources in this project. The agency is already well positioned at the international level. It is even more recognized outside Colombia’s borders than it is nationally. That is why I want to strengthen INVIMA’s position nationally. I also want to reinforce the legal part of INVIMA, by strengthening its legal department of sanitary responsibility.
What would you say personally is your main priority among those you just mentioned?
My top priority is INVIMA’s information system and the potential for users to consult updated and transparent information.
What would you be your final message to our readers, among which are your counterparts of other regulating agencies in the world?
Colombia has an efficient public healthcare vigilance system, in which INVIMA is a significant part and an important link of the chain, ensuring the consumption of safety products. Dear readers, foreign, Colombians, investors, and national and international companies: you can continue to trusting INVIMA’s system. If it has INVIMA´s seal, is because is safe, effective and quality.