The pharmaceutical industry plays a key role in improving people’s lives by discovering and developing medicines that prevent and treat diseases. Its constant investment in R&D allows scientists to better understand how the human body works and to find innovative solutions to complex health problems. Thanks to these efforts, millions of people around the world have access to safer and more effective treatments.
Developing a new medicine requires not only significant financial investment but also extensive human resources and time. Even for molecules with a simple structure, researchers must sift through a vast number of possible compounds to identify those with the most promising properties and desired therapeutic effects. Once the optimal molecules are selected, their safety and effectiveness must be demonstrated through rigorous clinical trials, which are also necessary for obtaining marketing authorisation. Finally, once the marketing authorisation is granted, the medicine can be made available to the public, while ongoing pharmacovigilance ensures that any potential risks to health are promptly identified and managed.
Therefore, protecting technology related to medicines is very important. Patents and other intellectual property (IP) rights give companies exclusive rights to sell their inventions for a certain period, helping them recover the money and effort invested in R&D. However, this exclusivity can be a double-edged sword. While it encourages innovation, it also means that new drugs are often very expensive, which can make it difficult for everyone who needs them to afford them.
Balancing IP rights with access to healthcare is one of the most important challenges in modern medicine. On one hand, IP protection is essential to encourage innovation and ensure that pharmaceutical research remains sustainable. On the other hand, strict IP enforcement can limit access to life-saving treatments, especially in low- and middle-income countries. Achieving this balance requires cooperation among governments, industry, and international organisations to design policies that both reward innovation and protect the right to health.
The following section provides an overview of the legal and technological mechanisms that can facilitate access to medicines, with special emphasis on the Mexican context.
Compulsory licensing
Mexican law establishes the granting of compulsory licences for reasons of emergency or national security, including serious diseases declared to be of priority concern by the General Health Council, when failure to do so would prevent, hinder, or increase the cost of production, provision, or distribution of necessities or medicines for the population.
From the above, it may be appreciated that application of this provision is not easy, since it requires an emergency declaration. In fact, there are no records that any compulsory licence has been granted in Mexico.
In contrast, countries such as Brazil and India have granted compulsory licences for the production and distribution of generic versions of pharmaceutical products protected by patents; for example, efavirenz, a medicament for treating HIV.
Another successful application of compulsory licences can be found in Ecuador, where the legislation provides a clear procedural guideline for the concession of compulsory licences for pharmaceutical patents. Under this guideline, the Ministry of Public Health must determine whether the requested medicine is used for the treatment of diseases affecting the Ecuadorian population and considered a public health priority.
The Bolar clause
Mexican legislation includes the well-known Bolar clause, which allows the use of patented inventions for the purposes of obtaining regulatory approval within three years prior to the expiry of the patent for allopathic drugs and eight years for biotechnological drugs.
This provision has played an important role in fostering competition within the pharmaceutical market, allowing generic manufacturers to prepare for market entry once the patent or patents related to the medicine have expired.
It is important to note that as a result of international agreements, Mexico has acquired the obligation to grant patent term adjustments for unjustified delays during the processing of a patent. Based on the abrogated North American Free Trade Agreement, an adjustment to the patent term could be sought on the ground that a patent should have an effective term of 17 years; i.e., from the date of grant of the patent.
On the other hand, the industrial property law in force is aligned with the provisions of the United States–Mexico–Canada Agreement, seeking to adjust the term of a patent to compensate for unreasonable delays directly attributable to the patent office that result in a period of more than five years between the date of filing the application in Mexico and the granting of the patent.
New technologies
In addition to exceptions to patent rights such as compulsory licences and/or the Bolar clause, the development of new technologies that facilitate pharmaceutical innovation by reducing costs and time could help improve access to medicines.
In this context, the advancement of new technologies is transforming the pharmaceutical industry by making drug development faster, more efficient, and less costly. Innovations such as AI, computational modelling, high-throughput screening, and advanced biotechnological methods allow researchers to identify promising compounds and predict their behaviour long before clinical testing begins.
These tools not only reduce the time and expense required to bring new medicines to market but also help improve safety and effectiveness by enabling a deeper understanding of how drugs interact with the human body. Ultimately, technological progress plays a key role in making healthcare more accessible and sustainable for people around the world.
In conclusion, ensuring access to medicines while preserving incentives for pharmaceutical innovation requires a balanced and flexible legal framework. Mechanisms such as compulsory licensing and the Bolar clause, together with the use of emerging technologies that reduce development costs and times, demonstrate that innovation and public health can advance in parallel.
In the Mexican context, continued collaboration between authorities, industry, and international partners will be essential to strengthen both the protection of IP and the right to health.
