Shortages of critical medicines and pharmaceuticals: legal and regulatory responses
Martín Mosteirin
Marval O’Farrell Mairal, Buenos Aires
Carolina Ramirez
Marval O’Farrell Mairal, Buenos Aires
Introduction
The availability of critical medicines and pharmaceuticals is a pressing global issue, essential to the foundation of public health and the effective delivery of medical treatment. This issue calls for decisive and responsive regulatory measures that address a sensitive situation. Shortages of these products can have a significant impact on patient care, causing an increase in healthcare costs and/or delays in treatments.
As one of the World Health Organization’s fundamental premises, governments are urged to take proactive measures to ensure that the population has access to safe and effective medicines. Argentina is not a stranger to this process and must adopt all those measures that favour the population’s access to quality drugs. Therefore, certain policies were implemented in the country, aimed at ensuring citizens’ consistent access to vital medications and pharmaceuticals.
This commitment is further reinforced by Article 42 of the Argentine Constitution, which sets forth the rights of consumers and users, including their fundamental right to accessing health services of adequate quality. Thus, the Constitution underscores the state’s duty to safeguard public health.
The National Agency of Medicines, Food, and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica or ANMAT) is the primary authority responsible for overseeing the pharmaceutical activity in the country. ANMAT is vested with the power to carry out those actions to prevent and protect the population’s health that fall within its competence (Article 3, Decree 1490/1992, which regulates the Law on Medicines 16463).
ANMAT has issued specific regulations to address shortages of critical medicines and pharmaceuticals products (eg, ANMAT Regulation 2038/2017). In essence, these regulations establish that those pharmaceutical companies that are marketing authorisation (MA) holders must adopt the corresponding measures to ensure the availability and accessibility of medicines.
It is important to highlight that Argentina is a federal country that is divided into 23 districts and the Autonomous City of Buenos Aires. Consequently, the regulatory framework related to healthcare is shaped by both federal and local laws, which may differ in their approaches and implementation.
Obligation to notify potential shortages of medicines
Pharmaceutical companies that hold an MA for a medicine registered under commercialisation status with ANMAT must notify this agency of any circumstances or facts within their knowledge that could jeopardise the supply of the products and cause their temporary or definitive supply market discontinuation in the local market (Article 1, ANMAT Regulation 2038/2017). The notification must be filed at least 180 calendar days in advance. Should this not be possible, it must be notified within five days of becoming aware of the relevant circumstances that could cause the discontinuation of products authorised by ANMAT.
This mandatory notification seeks to safeguard and maintain equitable and uninterrupted access to critical pharmaceutical products.
Permanent discontinuation of medicines
ANMAT is vested with the power to evaluate the existence of a therapeutic alternative when a permanent discontinuation of a medicine is reported, based on a commercial decision of the MA holder that is not linked to quality or adverse event issues.
Provided that there is a similar product available in the local market, the pharmaceutical company may proceed with the product discontinuation process by notifying ANMAT at least six months in advance through the affidavit available in Annex I of ANMAT Regulation 2038/2017.
In cases where there is no similar product available in the market, if the pharmaceutical company holder of the product MA decides to permanently discontinue the manufacture and/or importation and marketing of the medicine without sanitary grounds that could justify such decision, the pharmaceutical company must:
- inform ANMAT of such decision at least six months before discontinuing the manufacture and/or importation and commercialisation. The notification must be sent by filing a sworn statement, attached as Annex I of the Regulation; and
- ensure that the supply of the medicine to be discontinued continues during all this term.
Furthermore, ANMAT can urge other pharmaceutical companies that may be interested in filing an application to register the medicine to be discontinued after the MA holder has notified the decision to permanently discontinue the medicine (that has no similar product available in the market). Nevertheless, to our knowledge, there are no public precedents in which ANMAT has made a decision in this sense.
In a broader context, the issue of availability of medicines is also addressed through mechanisms such as compulsory licences, which allow governments to bypass patent protections.
Going back to ANMAT Regulation 2038/2017, until a potential new supplier can manufacture and market the medicine in the local market, the pharmaceutical company holder of the MA to be discontinued must ensure the supply of the product in the local market. The purpose of this statement of the regulation is to make sure that patients’ access remains undisturbed (Article 3). In practice, this implies that ANMAT may require that the MA holder extends the manufacture/import and commercialisation timelines of the product to be discontinued. This may present some challenges to multinational pharmaceutical companies, since product discontinuation usually follows instructions and timelines set up globally by supply chain headquarters for all the jurisdictions worldwide, and are not usually customised for specific countries – only for regions.
This regulation embodies a state policy rooted in a commitment to take preventive measures rather than merely reactive responses to shortages. It reinforces state control over pharmaceutical companies to ensure that commercial decisions do not compromise public access to essential treatments, and thus prevents medical shortages.
Recall or market correction of pharmaceutical products
A different type of shortage could be caused due to a product recall or market correction action usually triggered by a product quality risk. These situations are mainly ruled by ANMAT Regulation 1402/2008. This Regulation defines ‘recall’ as the definitive removal of a pharmaceutical product in the local market, when it violates the regulations in force or when it is suspected to do so. In these cases, ANMAT will initiate the corresponding administrative and/or judicial proceedings.
In the same vein, a ‘market correction’ is defined as the temporary removal of a pharmaceutical product from the local market to correct an error made during labelling and/or packaging. In these cases, ANMAT initiates the corresponding administrative and/or judicial proceedings. The product can re-enter the market once the error has been corrected.
In its Annex I, this Regulation establishes the definitions, responsibilities and general procedures MA holders must comply with to manage, follow-up and audit actions for the recall or market correction of pharmaceutical products from the market.
Recall or corrective measures could be caused by different situations (eg, violation of the current regulations that are not derived from a business commercial decision). This is another scenario in which a shortage of pharmaceutical products can take place. However, in these cases, the shortage usually derives from a justified decision to protect public health, which is different to the product discontinuation described in ANMAT Regulation 2038/2017.