Rafael Gual
Director General
CANIFARMA (National Chamber of the Pharmaceutical Industry)
/
Expert Contributor

Challenges in the supply of pharmaceutical goods and vaccines

By Rafael Gual | Wed, 03/17/2021 - 09:31

It is no wonder that one of the most pressing current topics is the possibility of having a vaccine widely available to the population. Fortunately, the collaborative efforts of the pharmaceutical industry have borne fruit, and now we know that there are already different vaccines in the world that will allow humanity to obtain immunity against the disease caused by the virus SARS Cov 2-2019.

The questions that remain to be answered are whether we will have enough vaccine doses in sufficient quantity, and more importantly, in a timely manner. There are a number of factors that impact directly on these two issues. Let’s analyze the three main ones.

First, the sanitary permits held by the manufacturers of the existing vaccines in the world are emergency authorizations, which prevent these companies from allocating their vaccines to private entities, since they are only for the exclusive use of governments in vaccination campaigns.

Second, in the face of an exorbitant demand for these goods, there is not enough capacity to produce vaccines beyond the commitments that already exist with governments, at least during this year.

Third, the vaccines will be distributed throughout the world respecting the order in which they were acquired by the different countries, which means that if the vaccine was not purchased, the country will have to wait for its turn to receive it. This is not hoarding; it is a matter of vision.

It is, therefore, fallacious to think that any entity other than the government will be able to acquire vaccines for sale in the private sector, at least during this year.

On the other hand, the status of the bidding process carried out by UNOPS for the procurement of health supplies does not look promising. The tenders were carried out late and the results to date leave much to be desired. The first two months of the year have passed and more than 50 percent of the contracts of the bids for patented and critical supply products for the first quarter have not been signed as yet, which has compromised supply.

In addition, the process for the acquisition of the remaining 1,183 pharmaceutical items was only carried out in February. The results are expected at the end of March, with possible delays, which would compromise the supply for the months of May and June. However, it is important to point out that Mexican companies quoted close to 80 percent of the demand in the initial call for proposals, so that along with the products that did not have any quotes and that reached 12 percent, it is foreseeable that the allocation of orders to the pharmaceutical industry established in Mexico will exceed 94 percent. Indeed, our country has a consolidated and internationally competitive pharmaceutical industry, and yet if there is no adequate planning, as has been the case since the 2019 bids, this is not enough for a timely supply.

The role of UNOPS in the procurement of medicines “concludes” at the time of delivery of the goods at the places designated for that purpose, with INSABI in charge of the process from that point on. Even in the case of products coming from abroad, the import procedures will be INSABI’s responsibility. Unfortunately, the distribution has been one of the most severe problems that the system has suffered from and which has persisted over the last two years. Currently, only two out of the 11 locations designated for the delivery of products in Mexico City’s metropolitan area are operating. This is why at present, deliveries of the first products are experiencing delays that are not attributable to the manufacturers, a situation that will worsen as a greater number of items are delivered.

A second and perhaps more worrying bottleneck is the designation of the state-owned company BIRMEX to oversee the distribution of all consumables. Paradoxically, six specialized suppliers were vetoed because they allegedly constituted an oligopoly, which was in theory synonymous with corruption (although there is not a single lawsuit in the case), to create a company that will now perform the function in a monopolistic fashion. This fact alone and the company’s inexperience in these functions are enough reasons to doubt their capacity to deliver the necessary pharmaceutical products and health supplies to every corner of our country, especially since medicines require special handling conditions, many of them in cold chain. In addition to these very serious issues, the distribution of vaccines will also fall to this company, which seems to be a titanic task if we consider the functions it used to perform in this field.

Lastly, one of the issues of greatest conflict for the industry as a whole was the regulatory function of our authority, which despite impacting almost 12 percent of the gross domestic product, presented a backlog of procedures never seen before. However, recent changes in this fundamental area of industrial activity reveal a new mentality and an entrepreneurial spirit that may well yield immediate achievements. Much of this will depend on open and timely communication with the regulated parties, which has been a pending issue over the last two years, but with this recognition, the experience and capacity of an industry that has fought and will continue to fight for Mexico can be put to good use. There might be a light at the end of the tunnel.

Photo by:   Rafael Gual