Under the current research and development model, the pharmaceutical industry has switched its focus towards the therapeutic areas that offer the greatest commercial benefit, which are often not aligned with public health needs. Consequently, it has ceased to be the great innovative industry that it had been during the last century.
The consequences are on display. The so-called ‘me-too’ or ‘follow-on’ drugs and evergreening* practices, complicate and delay the commercialization of generics and biosimilars that compete with originator brand-name products. Thus, in recent years, only a quarter of the drugs approved by the regulatory agencies represent a real therapeutic advance [1].
On the other hand, most of the research funding that has led to the discovery of the greatest radical innovations in the pharmaceutical field is public, that is, the innovative research is paid with taxpayers’ money [2]. This concern was described towards the end of the 20th century after analysing the added value of the new molecular entities, and it has been corroborated recently during the development of vaccines, diagnostic methods and treatments for the SARS-CoV-2 pandemic.
In Argentina, this model is replicated to a large extent. The commercialization of most drugs is approved through a regulatory reliance process, that is, by accepting an evaluation carried out by the regulatory agency of a country considered to have high public health surveillance.
Argentinian researchers discuss the implications of the current pseudo-innovation model for a country like Argentina, as well as the public policies, focused on the Public Production of Medicines (PPM) that could promote universal access and respond to the country’s health needs, which was published in Ciencia Tecnología y Política [3]. Several states have had PPM programmes for several decades and, in recent years, the strategy has become a matter of discussion in other countries such as the UK.
Argentina has approximately 40 institutions distributed throughout the country that focus on PPM. In this context, medicines are considered a social good, leading to the adoption of a production and marketing logic that entails several benefits. These laboratories supply the public health sector with drugs and medical devices at prices ostensibly lower than those offered by private industry. In a world in crisis, such as the current one, having public production capacity allows the country not only to respond to local health problems but also to ensure the supply of medicines regardless of the global geopolitical situation. It contributes to reducing the trade deficit by limiting the import of manufactured products and results in foreign exchange savings in a country with recurring balance of payments problems. The creation, in 2014, of the Agencia Nacional de Laboratorios Públicos (ANLAP: The National Agency of Public Laboratories) aimed to improve the articulation and coordination of the public laboratories through the establishment and strengthening of a network capable of responding to the health needs of the public system.
The authors concluded that leaving the last stages of research and development of new medicines and their production in the hands of the private pharmaceutical industry has allowed companies to prioritize their economic benefits and maximize profits for their shareholders. This in turn has reduced their interest in the development of new treatments to respond to public health needs. There are alternatives to this model, including the PPM.
*The practice of evergreening is where pharmaceutical companies make small patentable changes to existing products with soon-to-expire patents.
Conflict of interest
The authors of the research paper [3] declared that there was no conflict of interest.
Abstracted by Federico Piñeiro, Nicolás Chiarante and Matías Zelaya, Instituto de Salud Colectiva, Universidad Nacional de Lanus, Buenos Aires, Argentina.
Editor’s comment
Readers interested to learn more about biosimilars in Argentina are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:
Prescribing practices for biosimilars: questionnaire survey findings from physicians in Argentina, Brazil, Colombia and Mexico
Implementing a treatment registry for a biosimilar: continuous safety surveillance of the biosimilar Bevax® (bevacizumab) in Argentina
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References
1. New products and new indications in 2016: A system that favours imitation over the pursuit of real progress. Prescrire Int. 2017;26(182):136-9.
2. Mazzucato, M. El Estado emprendedor: mitos del sector público frente al privado. Barcelona: RBA Economía. Anthem Press. 2014;1-47.
3. Piñeiro F, Chiarante N., Zelaya M. Sobre la investigación, desarrollo y producción pública de nuevos medicamentos. Ciencia Tecnología y Política. 2020;3(4):1-8.
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