IGSS Board: Inaction in the face of health judicialization and abuse of sole providers

It was pointed out that this was the responsibility of the Ministry of Health – which I hope has woken up to pharmacoeconomics – without discussing the registration issue. Many suppliers with updated records do not have a contract with IGSS. The direct purchase method was and still is an abuse in dealing with clubs.

In addition, another topic that is little known to doctors and internal bureaucracies was discussed – which is the responsibility of the Ministry of Economy and the Economic and Government Cabinet – such as attracting foreign direct investment and internal technology promotion to form local industries, which is the national policy of civilized countries. In this regard, dialogue with chambers of commerce and different domestic and foreign suppliers is essential. It is regrettable that SICA and Central American Integration are so reluctant to promote these actions at the regional level.

On the judicialization of health-harmful monopolies Unique Supplier The first response of the technical institutions to the IGSS Board of Directors came in the opinion of the IGSS Market Intelligence Committee on March 2, 2021. That is, almost a year has passed since the Board’s decision (from June 2020) which ordered the technical institutions to find solutions both to protect themselves from the judicialization of health and to avoid the increase of the offer by a single supplier.

Before 2015, the chiefs were Agefinsa and JI Cohen, led by Gustavo Alejos and the family with the surname Jarquín. Then, the Giammattei era promoted Lanquetin and La Botica. But it is incredible that under the new government, there will be no changes in the governance of the IGSS at this stage of the party.

Let’s review some recent history: At the regular meeting of the IGSS Board of Directors on June 2, 2020, the following issues were addressed:

• Orders the Market Intelligence Committee to deepen its study of: a) Single-supplier drugs, defining what these drugs are and their procurement priorities; the suppliers that manufacture and sell these products, who are the commercial and legal representatives of these suppliers and their exact locations; b) Reports on the viability of patents and compulsory licenses and their global status. Their quality is considered a strategic issue in the World Trade Organization (WTO). The context of Guatemala and Central America; c) Directs that the results of the studies mentioned in the previous paragraphs be submitted to the Board and Management in the shortest possible time so that this information can be used in the negotiation strategy with domestic and international manufacturing laboratories. ; and the committees that the Board may designate from time to time to conduct these negotiations.
• At that time, the clerk delivered a rational vote, urging to deepen the work and solve practical problems related to policies related to pharmacoeconomics, which should take into account not only the regulations of the Ministry of Health, but also those of the Ministry of Economy, the inclusion of free trade issues, such as the free trade agreement with the United States, the possibility of exercising compulsory licensing, overseas procurement, and the full review of everything related to trademarks and patents for pharmaceuticals and medical surgical devices.
• Another director, Alan Jacobo Ruano, echoed these recommendations and suggested that in-depth analysis should be carried out when procuring from a single supplier and that procurement alternatives should be sought, with all possible studies and recommendations being carried out by the government, with the support of the board’s directive, so as to have a wider supplier base.

The strategy started to be designed and the following can be mentioned, which were apparently put on hold again in the management and the current board. The new government and the new Minister of Health should have pushed these measures through the National Health Commission. Let’s look at some of the circumstances at that time:

• Assess the potential for using new negotiation strategies to facilitate better purchasing conditions with the sole supplier (possible negotiation variables: amount, terms, quantity of product, drug, and treatment alternatives).
• Explore the possibility of adopting joint drug purchasing, that is, allowing expansion and competition for drugs with the same efficacy to expand the base of products and suppliers, awarding the most convenient alternative or a combination of these options.
• Explore the possibility of consolidating procurement approaches for pharmaceutical needs across countries and institutions through official regional and international organizations to increase purchasing power over foreign manufacturers or explore the feasibility of using international reverse auction mechanisms.
• Explore the possibility of using the procurement mechanism provided for in the Procurement Law, especially for those pharmaceutical products with therapeutic effects that are not available in the local market, allowing direct procurement through the Imported Goods and Services Committee (which is provided for in the relevant law).
• A market proximity strategy was implemented through information sessions with suppliers to understand the reasons: i) why suppliers of the studied medicines registered with the Ministry of Health did not participate in the procurement exercise; and ii) to explore whether similar therapeutic alternatives were available for consideration and evaluation by the IGSS.
• Additionally, provide a timeline for procurement activities in advance so that suppliers have time to prepare.
• Review of expiry dates of patent protection with the aim of recommending the introduction of bioequivalent generics and expanding the product range.
• Most importantly, a full defence was presented before the Labour Court and the Constitutional Court, warning judges of the grave responsibility they bear when ruling on issues of which they have absolutely no knowledge.

(frasepzp1)

Today, when the president of the IGSS, Mr. José Flamenco, appears in Congress, he always says that he has no choice but to buy the very expensive Aprovel from Lanquetin, because he is the only one offering it. Of course, everyone else colluded and agreed not to bid. It should be added that the price of Aprovel is 10 times higher than other “sartans”, Officially registered with the National Registry of Medicines. It turned out to be a deal by sentencing a prescription for Aprovir, which was unfortunately recognized by the magistrate.

In the past IGSS Board meeting, it was suggested to address the recommendations of another study presented by UNOPS, entitled “Feasibility study on a drug procurement strategy for a single registry of national regulatory authorities”. At that meeting, also in a meeting note dated December 3, 2020, the full Board began to discuss the issue of judicialization of health since 2017. After exhausting all efforts, criminal prosecutions were finally filed in 82 cases. Therefore, it is time to go on the offensive again on this issue to really understand what is really happening on the issue of judicialization.

First, we made a list of all the protections, reviewing the doctors and law firms that submitted them. Buying by brand has legal implications for those who issue decrees, including the highest judicial bodies. They have no experience of doing so, a conclusion I confirmed at the Ibero-American Social Security Congress in Buenos Aires, a meeting that included the highest experts in social security from a legal point of view, including the most prominent members from the Cabaneras Foundation. Cabaneras, as we all know, is the famous author of the Labor Law.

In Guatemala, buying by brand is explicitly prohibited. Then there is the window of compulsory licensing, widely used in South America and other civilized countries. Therefore, the Ministry of Economy, Trade and Industry and its trademark and patent areas, as well as the World Trade Organization regulations in this regard, should work on this aspect. By the way, the last point is something that the doctors and technocrats of the IGSS will never understand. But that is another story.

I consulted another dear former director of IGSS on this issue and he pointed out to me that it is advisable to check if it is indeed an imported branded medicine as there is no laboratory analysis to prove that it is indeed from the original manufacturer. A while ago, a warehouse of the above mentioned traditional chief was raided; a generic Indian product was being processed there and branded with a recognized manufacturer in order to sell it as original. So ask yourself, who can guarantee that Plavix and Aprovel from the single supplier shown are genuine? The worst part is that the national laboratory is not functioning and IGSS does not have its own laboratory.