There are many questions regarding the many medicines and medical supplies retained by Argentine Customs and whether this is due to the consequences of the "exchange rate restrictions" that affect foreign trade or whether it is only due to operational issues that, from a bureaucratic framework, affect the most sacred goal of a citizen, which is his right to health.
This work attempts to point out the various cases in which different citizens have been affected who, in order to protect their need to receive health medicine from abroad, were unable to access it due to a difficult mechanism that should be modified..
«Indeed, in practice, the import of medicines and medical supplies is one of the operations that has been affected by the so-called "exchange rate restrictions" since the State decided a few years ago to intensify customs and health controls. At least, this is how it has been thought since a more rigid framework has been implemented in order to maintain a stable trade balance that is increasingly deteriorating.
In recent years, there have been many complaints about the delays that have been occurring in this area, including what happened to a patient in Mendoza, who died in May 2014 in that city because she had to suspend her oncological treatment due to the retention of her medications in Customs while awaiting their release.That to the denial of the organism regarding such retention, the question put into debate the affectation constitutional rights that may be controversial, such as "access to health" and "the responsibility of the State in matters of health control" (validation of medicines from abroad), in addition to the regulatory power of the State in matters of economic policy and foreign trade.
The exchange rate cap and the import of medicines and medical devices
Among the consequences of the policy implemented since 2011 to prevent the outflow of foreign currency from the country, known as "exchange rate restrictions", the regulations issued by the AFIP to control and limit the importation of products through official mail or private postal services (Courier) stand out.
The established rules imply a series of worsening of the restrictions that already existed, whereby in order to remove the packages that are retained in Customs, cumbersome and costly procedures must be carried out, a circumstance that aggravates the situation of anxiety experienced by a patient whose medication with which he is being treated has been retained, which in itself generates more storage costs, because they usually require a cold chain.
If the patient is inland, an additional complication arises because the medication is only accepted at some Customs offices and the process becomes doubly difficult and costly because these arrival offices create cumbersome obstacles to sending the medications to their counterparts inland, which forces patients or their relatives to go to the arrival customs offices.
Compassionate use prescriptions
On the other hand, the National Administration of Drugs, Food and Medical Technology - ANMAT - carries out a process by which the so-called "compassionate use prescriptions" must be validated, that is, those that have prescribed medication that is not sold in the country. In this case, ANMAT must generate a document that is presented to Customs, which certifies that this requirement for imported medicine is authorized by the health authority, so that it can be delivered to the patient once it arrives in the country.
It often happens that ignorance of these prior procedures established in ANMAT provision 840/95 causes some of the delays, which then turn into waiting times with the medication retained in Customs.
Jurisprudence on access to medicines and medical devices
In the fatal case, with which we began this article, the patient had been suffering from cancer for 6 years and in the months prior to her death she had to resort to the courts to force the State to provide the medication, but even with the court order, the medication remained held up in Customs for a month and arrived when it was not possible to administer it due to the patient's terminal condition.
In this regard, the intervening court established that "As for the danger of delay, I believe that it is already present since it is known that, as a general rule, in matters that have to do with health, not applying a certain treatment for a period of time can lead to consequences that are later irreversible or very difficult to reverse."(file no. 250480/2014 “Guardia Graciela Beatriz v. Provincial State for amparo action”). However, Customs denied the interruption of the entry of medicines, stating that ANMAT must validate – as we said – the commercialization of the medicine, a process that cannot extend more than 48 business hours.
On the other hand, the deceased's relatives directly accused the State of the bureaucratic obstacles generated as a consequence of the exchange rate restrictions and added that the remedy had been authorized for several months. Ultimately, the Court granted the injunction with the reservation that the remedy had the corresponding authorizations, so the delay that the affected parties complained about could have originated in the greater zeal of the health and customs authorities, in line with the aforementioned current economic policy, tending to discourage imports to avoid the outflow of foreign currency from the country.
Another interesting case from a few years earlier had to do with the importation of percutaneous heart valves, whose entry into the country was stopped by ANMAT ("Chizzoli, Eduardo Antonio Vicente c/EN -ANMAT s/amparo ley 16.986" of 2008). The device in question was to be implanted in the actor, a patient who suffers from severe aortic stenosis - it is an abnormal narrowing of the aortic valve -. However, the Federal National Contentious Administrative Chamber confirmed the rejection of the precautionary measure that sought the immediate authorization of entry into the country, because it made the responsibility of the State in health policy prevail, "It should be noted that in order to assess this danger in the delay, it must be taken into account that the right to health and life of the appellant is being confronted with the obligation of the State to prohibit any possibility of epidemiological risk and the serious damage that this would cause to the health and life of numerous people, and with the evidence provided, it cannot be considered proven that, if the entry of a valve of bovine origin is admitted as a precautionary measure, there is no risk of the introduction of bovine spiniform encephalopathy (BSE) into the country.
In this case, it is clear that the priority of collective public health, which the court ruled in favor of, is related to the Social Interest, the Common Good, Public Order and the Police Power of the State. These concepts have to do with the individual limitations that the State can impose in defense of collective rights or due to an emergency. In this sense, it is emphasized that the individual rights established in the National Constitution are not absolute, since they can be regulated and restricted in their scope by the same constitutional precept that establishes the enjoyment of rights "in accordance with the laws that regulate their exercise."
However, when dealing with cases that put a person's life at risk and do not compromise collective public health, the courts choose to consider that the delay in the administrative process to resolve a claim for medicines made by the plaintiffs by virtue of their special state of health and economic situation, cannot translate into harm to their health and a possible risk to their lives, because in such a case the State's actions would be disregarding the protection of fundamental rights guaranteed by the National Constitution and international treaties (National Court of Appeals in Civil and Commercial Federal Matters, Chamber 1, case 3973/02 of 29-8-2002 and Chamber 2, case 3912/02 of 20-8-02).
The generic invocation by the State regarding the National Health Emergency has not been admitted either, “given the harmful consequences that this would have for the health of the plaintiff, a right of constitutional hierarchy (art. 75, paragraph 22, of the National Constitution; art. 25, paragraph 1 of the Universal Declaration of Human Rights and art. 12, paragraph 2, paragraph d, of the International Covenant on Economic, Social and Cultural Rights). From this perspective, the right to life is the first right of the person guaranteed by the National Constitution, and constitutes a fundamental value with respect to which the remaining values always have an instrumental character†(Errors 323:3229, 323:1339 and 324:3569).
In short, the right to health is fundamental, both individually and collectively, and includes access to health services and benefits in a timely, efficient and quality manner, with the aim of improving, preserving and promoting health from a broad concept that does not only imply the absence of disease. Within this framework and in the special cases that concern us, related to the entry into the country of medicines and medical devices from abroad, the State must adopt appropriate health policies to guarantee equal treatment and opportunities in timely, efficient and quality access to prevention, treatment, rehabilitation and palliative care for all citizens who need them.
The urgent need to observe an immediate release of medicines and health supplies in practice
It is unquestionable that health is above the economic and foreign trade policy system, and in consideration of this, the State, from its power to control the entry and exit of merchandise traffic, which is exercised by the General Customs Directorate (Law 22.415 - Decree 619/97), as well as by ANMAT health controls, must try to combine a simplified and very summary regime when dealing with the entry of medicines or urgent supplies for individual or collective health. Bearing in mind that hours or days of delay can lead to what has already happened in practice, the loss of a person's life or worsen their health condition.
In this context, it should be made clear that it is not necessary to dictate regulations so that the entities that exercise the power of control must adapt, given that the General Directorate of Customs - AFIP - has sufficient powers to facilitate the simplification of these mechanisms and release in such cases urgently at the time of arrival of the merchandise. Both arrival through special regimes - mail - courier - luggage - or before importation under the general system - import clearance - must allow its entry without restrictions. It does not escape any mortal, that the requirement in the general regime of requiring a DJAI, is well known in practice, that they are impossible when attempting their purpose and/or eternalized in the time that proclaims the need for immediate use in the sick.
These types of measures do not in any way affect the powers of customs or health authorities, since their "direct delivery to the market" in these cases does not prevent the proper control of their use for the purpose for which the urgent delivery request was made.
When life is in danger, administrative systems and/or regulated procedures cannot in any way prevent the urgent achievement of the goal, which is to save the life or maintain the full state of health of the person who requires it. This is the basic rule, which since 1853 has been clearly proclaimed by our National Constitution above other norms of lesser rank, and the State's control bodies must try to align themselves with such a sacred right to life.
Dr. Ignacio Millé
