Pharmaceutical Accountability Foundation

Solution #3: Strong enabling environment

Governments and intergovernmental bodies have the power to set better legislation or to better enforce existing legislation in order to optimise innovation and access to meet pressing public health needs. Countries can enforce the affordability, accessibility and availability of medicines through the use of – unfortunately often unused – laws and regulations. Public awareness can also play a key role.

Strong enabling environment: Solution contents

There are several solutions that governments and their citizens can take to improve the enabling environment for access to medicines.They include:

Related Issue: Poor enabling environment

Medicinal products are not always accessible or affordable for those that need them. There are many reasons for access problems, including monopolies that limit competition, high prices, weak health infrastructure or regulatory barriers.

Public awareness

A legal and policy environment that serves the public interest rather than purely industry interests can be fostered by putting pressure on policy makers and informing the general public on important health topics. Strengthening public awareness on access to medicines is vital to ensure that the public is aware of the issues that arise when pharmaceutical companies operate in legal and policy environments that are not designed well enough to serve public interest. The public has an important role in influencing national and international decision making, which can improve the application of laws and ensure that public interest is respected. 

Pharmaceutical Accountability Foundation raises public awareness on important health issues through advocacy and awareness campaigns.

Lobbying members of parliament

Lobbying Members of Parliament (MPs) and Members of the European Parliament (MEPs) can be an important strategy to influence decision making and ensure that public opinion is respected in the decision making process. 

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Competition Law

Competition between different pharmaceutical companies is one of the critical success factors when it comes to making medication affordable, accessible and available. An important example are antiretrovirals (ARVs) , where  the cost dropped from $10,000 per person to less than $300 a year after the manufacturers decided no longer to defend their patents during the HIV/AIDS crisis in South Africa around 2001. This was the result of an international ‘naming and shaming’ campaign, but also from a competition law case  (Hazel Tau vs GSK and Boehringer Ingelheim; see UNCTAD and KEI reports.)

A more recent example is the 2017-2021 Aspen EU case where Aspen had to reduce six off-patent cancer medicines by 73% addressing excessive pricing concerns by the EU Commission.

The pharmaceutical industry is notorious for its never-ending quest to make monopolies last as long as possible. Nevertheless, competition law is rarely used as an instrument to lower prices. 

The Pharmaceutical Accountability Foundation uses this means to combat improper competition. See our Cases for more information.

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Fair patenting/patent opposition

Most countries’ patent systems contain safeguards against their abuse to create ever-longer monopolies that benefit companies but not the public. But if these safeguards are not used, or are used ineffectively, then the functioning of the patent system can be sub-optimal. Examples of this can include: use of weak patentability criteria, which can allow patents to be granted for derivative drugs that are essential copies of existing treatments, or for treatments that are not sufficiently innovative; poor application of pre- and post-grant patent opposition, which is used to challenge a patent’s legitimacy; and discouragement of government use or compulsory licences, which give a government or other entity the right to produce a generic product without the consent of a patent holder. Transparency can also be an issue in patent systems. Patents can be challenging to read, and are often written that way on purpose, and multiple patents can be layered onto a single product, making it challenging for would-be generic producers to determine their freedom to operate.

When it comes to patent monopolies, there are several ways to break them. The first concerns fair granting of patents: care is taken that the patent only comprises a medical innovation that also has significant added value for public health. This avoids the granting of patents for modified products or products with a similar function to products already available on the market, instead of completely new products.

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