Of policy space and actors in the policy space: The role of courts in developing countries in IP policymaking

Anyone working in the field of IP law from developing countries particularly on the African continent understands the tension between IPRs and access to IP-protected materials based on human rights imperatives. Even if only from a development perspective, the socio-economic context and needs of citizens in developing vs developed countries differ in significant respects. Dr Emmanuel Oke’s book, Patents, Human Rights, and Access to Medicines (Cambridge University Press, 2022) examines the resolution of the tension between patent rights and the right to health through the lens of the decisions of national courts and tribunals in Kenya, India and South Africa. Oke’s examination and the resulting recommendations provide excellent guidance for those working in the field of IP law in developing countries particularly those interested in understanding how the organs of state may work to ensure that the exercise of patent rights does not erode or adversely affect the right to health and access to affordable medicines.

In the light of the high incidence of communicable and non-communicable diseases prevalent in developing countries, there is need for these countries to take necessary steps to facilitate access to medicines at affordable prices for their citizens. One thing standing in the way of this 'mission', according to Oke, is the current global system for IP protection as embodied in the TRIPS Agreement. In his view, the way that the TRIPS Agreement is structured including the practical implementation and interpretation of its provisions severely constrict the policy space available to developing countries to design their IP policy in a manner that addresses and suits their needs. Oke defines policy space as “the freedom that a country has to design its national policies, including intellectual property policy, in a manner that suits its need and level of economic development”. See p.4.

But all is not lost for while the policy space has been severely reduced, it is not completely eroded. In terms of patent policy (which is the focus of the book), some of the areas where policy space still remains include: freedom to exclude new forms of known drug from patent protection, the freedom to adopt the principle of international exhaustion of patent rights to facilitate the parallel importation of drugs, regulatory review exemption for producers of generic drugs, research exception, compulsory licenses and delinking the grant of marketing approval for generic drugs from the patent status of branded drugs.

To understand some of the political and other challenges that developing countries face in utilising available policy space, it is possible to draw parallels between the outcome of the COVID-19 TRIPS waiver discussion and the outcomes of the list of demands made by developing countries in their proposed draft ministerial declaration (Doha Declaration) as Oke analyses them. Out of the 14 demands made in 2001, the Doha Declaration only addressed six demands and most of these were demands relating to existing flexibilities in the TRIPS Agreement and so their inclusion in the Doha Declaration merely confirms the provisions of the TRIPS Agreement. Similarly, the declaration adopted in respect of the COVID-19 TRIPS waiver and the original/initial draft proposed by South Africa and India was significantly different and, in many cases, served to confirm the provisions of the TRIPS Agreement. Some Katposts here and here.

Nevertheless, Oke argues that paragraph 4 of the Doha Declaration approves of the incorporation of a right to health perspective and a model of human rights into the design, implementation and enforcement of the national patent laws of developing countries. How this incorporation is to be undertaken and which organs of state are to undertake the incorporation also form the focus of Oke’s book. In that regard, Oke’s discussion of the extent to which the courts and tribunals in India, Kenya and South Africa have incorporated a model of human rights in adjudicating disputes involving patents and the right to health suggests that courts are and should be involved in policy-making particularly in the IP policy space.

Oke’s book takes for granted or operates on the acceptance of the value, legitimacy and desirability of judicial IP policymaking in India, Kenya and South Africa. For South Africa, cases examined are: Soobramoney v Minister of Health; Minister of Health & Ors v Treatment Action Campaign & Others (No. 2); and Minister of Health v New Clicks, which deal with the interpretation and effect of constitutional provisions on the right of access to health care services; and Pfizer v Cipla MedPro; and Aventis v Cipla, which deal with the tension between patent rights and the right to health.

However, in the judicial policymaking process, Oke highlights the reluctance and approach of the courts in not crossing the line set by the doctrine of separation of powers. See p. 122. In the case of South Africa, Oke points out that the South African Constitutional Court, in addressing a challenge to its orders on the ground that according to the doctrine of separation of powers, the making of policy is the prerogative of the executive and not the courts, held that the doctrine of separation of powers does not mean ‘that courts cannot or should not make orders that have an impact on policy’. See Minister of Health & Ors v Treatment Action Campaign & Others (No. 2).

Oke’s book provides a logical and thorough assessment of patent rights as they relate to affordable medicines, explains why preservation and utilisation of patent policy space is crucial for developing countries, and suggests ways that governments (and courts) in developing countries can improve access to affordable access by incorporating a model of human rights in all spheres of patent rights – design, implementation, interpretation, and enforcement. usability. As he concludes, “since states bear the responsibility to respect, protect, and fulfil the right to health and secure access to medicines, countries that are parties to the ICESCR have an obligation to preserve their patent policy space in order to ensure that access to affordable medicines is not impeded by the implementation and enforcement of excessively hogh levels of patent protection...the incorporation of a model of human rights into a country’s national patent law system will not be in conflict with its obligations under the TRIPS Agreement”. See p. 165.