In the midst of the crisis in the Colombian health system, the pharmaceutical sector has been one of those that has raised its voice the most due to the impacts that this can generate for the industry and patients.. The slowness in the management of procedures that has slowed the arrival of some medications to the country, added to the shortage of drugs and the discussion on legal certainty and intellectual property after the declaration of public interest of the drug dolutegravir, have been some of the key topics on which they have spoken.
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Many of these pronouncements have been led by the Association of Pharmaceutical Research Laboratories, which represents 29 global companies in the country.
In an interview with EL TIEMPO, María Clara Escobar, executive president of Afidro, warns that there is concern in the sector about what may happen from the changes that the Government is promoting.
Furthermore, it points out that a transition of the EPS towards actors who do not know how the system works and who do not have enough information to operate can result in a negative impact for patients.
“At the end of the day not only the industry suffers, but also the patients“says Escobar, and warns that beyond reform projects, what should worry the country is the current critical situation of the sector, driven by the insufficiency of the UPC.
Health Forum and 30th Andi Pharmaceutical Forum.
Photo:Andy
What problems does the pharmaceutical and research industry in Colombia face today?
We are an industry that has been in Colombia for many years, that has always been committed to the country, that in the last 30 years has been present in a system that has guaranteed access by all Colombians to innovative medicines.
That is to say, in Colombia patients, regardless of their geographical location or social conditions, have had access to innovation and this shows that in these 30 years there has been a system that works, in which The efficiencies generated by its structure, in a great alliance between the public and the private, have allowed us to have one of the best systems in the world with access to our medications.
The threats we are seeing to the functions that the EPS have played for 30 years in our system
Now, with this context we are very concerned with this new proposal that the Government has, with what it intends with the health reform, but also with some actions that one could call a de facto reform. Because these types of public health policy actions and specific decisions point to a system with much more control of the public.
In order not to remain in such a broad discourse around the problems of the system, I am going to talk then about the purchasing system and the flow of resources derived, of course, from the purchases of medicines and innovative medicines. The threats that we are seeing to the functions that the EPS have played for 30 years in our system – from our point of view and without being very clear about what comes next -, Because the Government has not been clear in this regard, we are concerned because in some way it could destabilize or unbalance medicine purchasing systems that have operated with efficiencies, with economies of scale.
For the pharmaceutical sector, today the lack of legal security with intellectual property is of concern.
Photo:CityTv
The EPS in the institutional channel, which is where we have the vast majority of our medications, make this purchasing system and use the possibility that they have of knowing their members, they know their patients enough to be able to carry out purchasing procedures with great efficiencies. And yes, that can change in some way, there is great uncertainty on our part to know how these processes are going to be organized. It is one of our great concerns.
In general, and I think like other actors, the financial sustainability of the system worries us a lot. There is an issue here, also to continue with the flow of resources throughout the chain: it starts from the Adres, goes through the EPS, then to the pharmaceutical managers and then to us, in the last link of the chain. Everything that is happening in financial terms is already affecting us. There are portfolio delays. This is like a domino, in which, being at the end we see the last delays, let’s say, of the arrears in the portfolio. That has us quite worried, because at the end of the day not only does our industry suffer, but the patient ends up being the most affected by the lack of medicines.
What can happen if the EPS are replaced by an actor who is unaware of how the system works and does not have that data to be efficient?
Loss of efficiencies. And when efficiencies are lost, in our case in the purchasing mechanisms, then again what can occur is shortages and shortages, which will necessarily end up being a problem for the patient.
Talking about shortages and shortages. Has Invima managed to solve the problems that you had pointed out since the beginning of this year?
I believe that the commitments that Invima made, especially as a result of a plan that they presented at the request of the Administrative Court of Cundinamarca, I believe that the goals that were set for the decongestion of procedures and their advancement, are not they have fulfilled. This is in the words of the Invima director himself, who has shown the progress, but has also stated that this plan has not been fully fulfilled at the moment.
In that sense, it is worth highlighting that the procedures related to our medicines, with innovative medicines, were proposed to be brought forward to the end of the plan. That is, what they determined was the long term. Nor have we seen speed or a strong decision on the part of Invima to manage these procedures for our medications expeditiously.
Speaking of innovative drugs, how are these drugs that usually take several years to obtain registrations? Something that several actors have complained about…
There are many cases in which the laboratories themselves have great uncertainty regarding the delays in a process of granting, for example, a health registration, compared to other countries in the region in which there is much more speed and much more effectiveness. in those procedures.
In clinical research there are also important delays in Invima and in those terms too We are competing with other countries in the region who have much better conditions and more certainty for this type of activities in the countries and obviously they are activities that are going to other countries and we do not see a great opportunity in Colombia. And it is sad because Colombia has good capabilities, it has good research centers.
Another thing that you have questioned is that there is a risk regarding intellectual property, regarding what happened with the patent granted to the drug to treat HIV, dolutegravir…
The biggest problem, as I see it, is the legal security that is given to investments in the country, not only in our sector, but it is also a message that is given to the productive sector, to companies, to the sector. private.
The entire scheme or the assurances that the country gives through respect for intellectual property rights are nothing different from granting exclusivity times for the marketing of a medicine, a molecule, in which there are no competitors for a period of time. time.
What happened with dolutegravir is that it has a current patent and despite the fact that there are some flexibilities, in the international regulations that Colombia has accepted, that allow what is called a declaration of public interest on a medicine for the subsequent granting of a compulsory license. Although this is possible, it is an exceptional mechanism.
What does this mean? That if the country demonstrates that there is an emergency situation and that patients are not having access to a medicine, public interest in it can be declared. In the case of dolutegravir, the justifications given by the Ministry of Health for the declaration of public interest have not been sufficiently consistent with reality and, above all, with what the regulations contemplate.
EDWIN CAICEDO
Environment and health journalist
@CaicedoUcros
