Drug prices and trends before and after requesting compulsory licenses: the Ecuadorian experience

ABSTRACT

Introduction: The Ecuadorian Institute of Intellectual Property (IEPI) granted several compulsory licenses between 2011 and 2017. In 2009, the President of Ecuador signed a decree that was intended to facilitate the request of compulsory licenses (CL) in the country, not only for Enfarma EP but for any privately owned local company in order to produce more accessible medicines.

Areas covered: The national and international regulatory framework of pharmaceutical patents and the local applicability of CL in Ecuador. The authors also analyzed the results of requesting unplanned and epidemiologically unnecessary CL at a national level. Finally, the authors reviewed the effects of requesting, granting or denying CL on price per unit in the last 7 years of available data.

Expert opinion: The authors think that compulsory licenses are useful tools when negotiating drug prices or when the demand cannot be satisfied due to economic constrain within the local health system. However, the authors’ experience suggests that Ecuador did not have an established and reliable production system neither an adequate plan before requesting CL, therefore the positive effects of this measure were not clearly established.

KEYWORDS:

• Compulsory licenses
• Ecuador
• patent
• generic drugs
• Enfarma

Article highlights

• This study is the first analysis of this type in the Ecuador. It was generated in order to identify and evaluate the possible effects of requesting compulsory licenses on prices’ variability over the years after requesting them.

• Unique information was gathered in terms of prices before and after the request, granting or denial of compulsory licenses in the country.

• This investigation is probably the first one in analyzing the negative impact of CL worldwide. An interesting piece of information that can be used as a negative example of unplanned and poorly implemented legislation.

This box summarizes key points contained in the article.

Authors’ contributions

E Ortiz-Prado was responsible for the full conceptualization of the study and was in charge of drafting the manuscript and analyzing the data. G Cevallos-Sierra and E Vasconez were responsible for reviewing the gray literature related to this case and to offer their insight into the political context in Ecuador. E Teran was responsible for obtaining the data related to units sold and related costs. L Gómez-Barreno and K Simbaña-Rivera were responsible for the in-depth literature review and the drafting of the final manuscript. D Borrero Maldonado and J Ponce Zea were in charge of supporting the team in the legal context of compulsory licenses in Ecuador.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.