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.

Of policy space and actors in the policy space: The role of courts in developing countries in IP policymaking Of policy space and actors in the policy space: The role of courts in developing countries in IP policymaking Reviewed by Chijioke Okorie on Monday, August 14, 2023 Rating: 5


  1. To summarise: Companies in The United States, Europe and Japan should pay for the development of new medicines. Their citizens should fund this development through paying high prices that many of them cannot afford and will go without. Elsewhere, there is a basic human right to access these medicines, manufactured by profitable enterprises that do not invest any of their profits in research and development of new medicines.

    This is the current model, so what is the proposed change? Squeeze them for more!

    The industry is under increasing regulatory pressure to lower drug prices in the US and Europe. It is these high prices that subsidise lower prices elsewhere. Research will continue move in the direction of diseases where a return on investment can be achieved leading to further moves towards US patients. Obesity drugs are high fashion in the US, thankfully for those in Europe requiring treatment, because there is little profit there.

    Calls to run clinical trials in Africa to enable more relevant regulatory approvals will fall on deaf ears unless the funds are forthcoming, but look outside of the pharmaceutical companies. They won't be selling so won't be paying. Try Cipla.

    By all means use the right to self-govern to weaken or abolish TRIPs. The United States and Europe can focus on their own problems; cheap imports and overseas service providers destroying local jobs, which can be solved by raising tariffs. With the WTO only benefiting the rich countries it is time this was abolished.

    1. Not sure if we read the same review, but as the review notes, this book is about the role of national courts in addressing the tension between patent rights and access to medicines from a human rights perspective. Nothing is said in the review about what the author of the book thinks about pharmaceutical companies (or what they should or should not do). Moreover, I am sure if the author of the book was advocating for the abolishment of TRIPS, that would not have escaped the attention of the reviewer as that would be a rather radical claim that would be hard to miss. By the way, if you have read the book itself, as I have, nowhere does the author advocate for the abolishment of patent rights or TRIPS.

      So, your comment above seems like accusing a cat (pun intended) of not barking like a dog.

  2. @Realist: Not sure if we read the same review, but the one I read states: "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."

    I haven't read the book, but congratulations to you for having done so and I take your word that pharmaceutical companies are not referenced, however strange that is in a book about access to medicines, TRIPs and so forth.

    The abolishment of TRIPs is a suggestion that comes from me (the clue is I wrote it) and it is based on the position that TRIPs is an agreement whereby we all give something in return for something. If TRIPs is standing in the way of access to medicines then amend it or abolish it. Either course will result in the weakening of IP rights for pharmaceutical companies, but will enable those countries that do not wish to provide IP rights for new drugs to provide them to their citizens at reduced cost. TRIPs/IP cannot then be said to be "standing in the way of this 'mission'." That is "pragmatism".

    My points are clear. Firstly, without IP protection as embodied in TRIPs, there will be less investment in R&D and so a significant reduction in new pharmaceuticals being approved. Others offer alternative methods for developing new drugs and I wish them well; TRIPs/IP is not blocking their work, but the vast majority of new drugs do and will be produced thanks to IP.

    Secondly, all healthcare is expensive and there are many who cannot afford high-priced drugs. The proportion of people on the planet that cannot even afford access to low-price, readily-available, generics of essential medicines is not much lower. Those unable to afford healthcare include many who live in the rich countries of the United States, Europe and Japan, yet it is those countries that others believe should pay for new drug development. So a question from me is do citizens of rich countries have a basic human right of access to medicines or is that limited to those from poor countries?

    Without the high prices in the US, now under challenge from many, with the blame pointed at IP (ignorantly), there will be no more new drugs. To be clear, investment in pharmaceutical R&D will cease and the investors will move their money into new social media platforms and other areas "key" to survival. That is "realism".

    The role of India is not one of concern from human rights and access to medicines, but one of access to the markets for its generic industries. Lower priced drugs for those markets is merely a side benefit.

    And my final point is simply that the benefits of the WTO for poor countries is significant in that it provides access to rich markets. Whether this benefit has been achieved in reality is not for me to say, but if not that may be due to positions such as "fortress Europe" form a protectionist EU. If any country believes the balance favours withdrawing from the WTO to allow lower-cost medicine access, that is a decision for them. If rich countries do not want to open up their markets to those who do not provide for protection of their IP, that is also their right. It is also the current position.

    If my comments are completely irrelevant to the topics addressed in the book, that may be down to the review.

    1. Thank you for admitting that you have not read the book. Also, yes, your comments are largely irrelevant to the topics addressed in the book, and I don't see how that is down to the review. The book is about the decisions of national courts and that is the focus of this review.

      We can have debates about the role of IP in pharmaceutical innovation, but again that is not the focus of this book or review. What would be helpful is if you can provide empirical studies and data to back up your assertions that stronger IP rights always lead to more innovative drugs. I hope you will be able to supply evidence to show that more new drugs have been approved annually in the last 30/40/50 years due to higher levels of patent rights; and by new drugs, I don't mean drugs for cosmetic ailments or trivial/minor modifications of existing drugs.

      Of course, property rights can incentivise investment but that does not necessarily translate to more innovation. I think you are conflating more property rights with more innovation. That is not to say patent rights or IP rights are not important (and the author of the book does not say they are not important) but, perhaps, we should be more 'realistic' about the precise role of IP rights in innovation.

    2. @Realist: I think you missed my first sentence, which I shall repeat:
      "@Realist: Not sure if we read the same review, but the one I read states: "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.""

      This being a free country, I chose to address this statement. If that statement is not relevant to the book, so be it, my comment is on the statement as made in the review. If you don't like that, which you clearly don't, tough.

      As for needing to provide empirical evidence as you insist, thank you for the offer, but if you, or anyone else, is of the opinion that IP rights are not responsible for protecting, and therefore supporting, the mega-investments of many 100's of billions of dollars in new pharmaceutical R&D, then I'm afraid I'll have more chance of convincing flat-earthers that the earth is round by taking them on a trip with Virgin Galactic.

      If you think type-II diabetes and related obesity, leading to millions of premature deaths and significant healthcare costs, which will be reduced by the latest medications, is a cosmetic ailment, then you are not really a "realist". IMHO, of course.

      You presumably believe all drugs are trivial/minor modifications of the existing drug aspirin, but thankfully we have scientists who understand what the pretty pictures mean. As in, scientists who are able to understand the differences between molecular structures and the pharmacological differences due to those structural differences. Unfortunately, there are groups with loud voices, who failed science at school so went on to do other subjects, only to come back to be experts in the pharmaceutical field, so maybe you have read some of their uneducated, unscientific, biased, baseless, laughable propaganda. I find the Beano more realistic myself.

      Where you aware for instance that the simple addition of a neutron to a photon can result in a molecule with a different metabolic profile, such that the modified drug may be more suitable to treat a certain sub-group of patients than others? Such an advance that the ill-informed naysayers would call trivial/minor may provide patients having a certain genotype related to cytochrome P450 with an option they never had before. As said above, this is why it is important to conduct clinical trials amongst populations of different races, such as in Africa, before obtaining regulatory approval.

      You were not aware? I'm not surprised.

      Warning - do not try to add a neutron to a proton at home. Look what happened to that physicist in that new Barbie film. The outcome (everyone turning pink) is much less problematic than that which would result from going down the road of destroying the pharmaceutical IP system, which is jumping out as your particular ideology. But admitting that may mean you have to find a new livelihood, a new cause for self-promotion.

      I think the admission that I haven't read the book is the best win you will get on this subject. Why that is a win, however, is beyond me but fill your boots.

    3. Yes, 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. 'Mission' here being facilitating access to medicines - which is a global issue, not just something affecting developing countries. So, I am not disputing that. But Oke goes on to note, as the review highlights, that there is still some policy space that countries can use to promote access to medicines. Mind you, both developed and developing countries can and do use this policy space. So, I am not sure why this is a developed vs developing country issue for you. In addition, saying states can use the policy space in the TRIPS Agreement is not the same as saying that TRIPS should be abolished. So, it is not clear to me what your point here really is.

      I guess I thought it wasn't too much to ask for evidence to support your bold claims and assertions. Instead of studies and data, all I can see from your reply are strawman arguments. I already said IP rights can incentivise 'investments' (you can call it 'mega-investments, if that suits you better) - so no one is debating that with you. What I asked for was evidence of the link between higher levels of patent protection and an annual increase in genuine pharmaceutical innovation as shown via approvals for new drugs. But I suppose that is too much to ask for.

      Also, no one here (Oke, the reviewer, yourself, or me) is calling for the destruction of the pharmaceutical IP system. Pointing out that there are problems with a particular system is not the same thing as calling for its destruction. So, not sure what you are really on about, tbh. I am still waiting for concrete evidence from you. Once you have something other than strawman arguments, please let us know.

    4. Thank you for admitting that IP rights can incentivise 'investments'. You haven't justified your assertion that obesity (the disease mentioned in my original post) is a cosmetic ailment. Sounds like you think Americans deserve to suffer from being overweight. Nor have you justified your assertion that all the pharmaceutical industry is doing is making trivial/minor modifications of existing drugs (aspirin wasn't even developed by the industry but by a tree!). Do you have any understanding of molecular structure and structure activity relationships? No, so you have been buying the nonsense produced by those whose high income comes from defaming the industry with their click bait, buy-my-article, fund-my-privileged lifestyle arguments, and then regurgitating it. My income comes from protecting the industry that develops new drugs to treat disease, including obesity. The patents don't block access to any medicines - it just means those that those care about the poor need to put their hands in their pockets, while those who purport to care prefer to misrepresent patents and the industry.

      The developing country link? Try "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.". The clue there is in the use of the terms "developing countries".

      Evidence of the effect of "higher levels of patent protection"? What higher levels? The United States has been reducing patent rights for many inventions thans to the Supeme Court, but you won't hear about that in the articles I refer to. The Bolar provisions gave increased options to generics. TRIPs has resulted in huge increases in Chinese R&D spending and patenting - try WIPO's website for numbers of patent filings by country, see China's increase then look at the number of science/medicine articles produced in China.
      The implementation of TRIPs in the 2000's was in countries where there was limited patent protection, practically non-existent for pharmaceuticals, and those countries had large generic industries. Most still don't have any industry investing in R&D. The biggest investors in R&D are have always been in countries where pharma patents have been available and the investment has grown sginficantly since pharmaceutical compounds have been directly protectable. A simple comparison of the new drugs from countries that support drug patents versus countries that don't should provide all the evidence you need. But, all the evidence will not change your view, because it does not suit your position.

      Feel free to have the last word.

    5. Right. So, no concrete evidence then! Just more strawman arguments.

      I never asserted anything about obesity, you brought up obesity. I certainly never said that 'obesity … is a cosmetic ailment'. You can check my previous comments. I equally never asserted that 'all the pharmaceutical industry is doing is making trivial/minor modifications of existing drugs'. Again, please read what I wrote very carefully and don't put words in my mouth (so to say).

      By the way, thanks for confirming that the US also makes use of the policy space available to all countries under international IP law. You can call it 'reducing patent rights', if that works for you. Also, higher number of patent filings does not necessarily mean more innovation, irrespective of the country where it occurs. In some countries, patents are not even substantively examined, you simply fill out a form. And even in countries with a substantive examination process, you can still obtain patents for trivial inventions.

      Please feel free to get back to me here once you have the evidence I asked for i.e. empirical data or any standard peer-reviewed study to support your assertions and claims. I will be waiting. Have a nice weekend.


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