Innovation Patent

Delhi HC Orders the State to Foot the Bill for Rare Disease Treatment


Image from here

Image from here

In a remarkable moment for Indian jurisprudence, Manmohan J. of the Delhi High Court recently ordered the Govt. of NCT and the AIIMS (in Mohd. Ahmed v. Union of India) to provide a child suffering from Gaucher disease (a rare disease) Enzyme Replacement Treatment which costs about Rs. 6-7 lakh a month, free of cost. The court goes on to hold, in no mixed terms that the defence that the State’s funds were insufficient to meet such expenses would not really have bearing in the face of something as fundamental as the right to health – what the court also describes as ‘a core obligation’. The court states that the State is under an obligation to provide access to essential medications at affordable prices under Art.21 of the Constitution. It notes, quite poignantly, that just because someone is poor the State cannot allow them to die.

Gautam Bhatia’s post here analyses the constitutional aspects of the decision, and he makes some interesting observations which I would like to emphasise here. He notes that the court has finally bought some much needed clarity to the content of the right to health under Art.21 of the Constitution. He goes on to observe that the “….Court brings determinate standards to its Article 21/right to health jurisprudence. This would be helpful in future cases involving the right to health.”

He also raises another important observation in his post as to how this decision follows the trend prevalent in other countries, that of the “constitutionalisation of IP”. He notes that even in situations where pure IP rights are in question, the Constitution is relevant and can provide a valuable framework for deciding disputes regarding matters like copying of textbooks as fair use, compulsory licensing disputes and S.3(d) claims. The court has used the reading of rights under Part III to overcome obstacles that the IP regime may impose upon society.

The implications of this judgement are quite far reaching. Para 86 which states that the “Government is bound to ensure that poor and vulnerable sections of society have access to treatment for rare and chronic diseases, like Gaucher especially when the prognosis is good and there is a likelihood of the patient leading a normal life” raises the question of whether the decision can be extended to other (chronic) diseases.

Para 87 goes on to state, “Although obligations under Article 21 are generally understood to be progressively realizable depending on maximum available resources, yet certain obligations are considered core and non-derogable irrespective of resource constraints. Providing access to essential medicines at affordable prices is one such core obligation.”

 The court has made clear that the argument of resource constraint is not necessarily a sufficient one when the question of health is involved. In the decision, the Court also points out that this is a weak argument especially when some are treated more ‘equal’ than others when it comes to resource distribution – when it points out, “Government of NCT of Delhi which was taking the stand of financial constraint in providing treatment to the petitioner, had reimbursed Rs.1.32 crore as medical expense to a MLA from Rohtas Nagar.”

Some time ago we had carried a post on rare diseases and we pointed out how we had NO policy mechanisms in place in India to promote access or even R&D for innovation into these in contrast to other counties (like the USA) which have legislation which has achieved a certain degree of success. Before this decision, policy makers could hide behind the veil of inadequacy of funds / risk takers to explain away the lack of treatment / investment caused by these policies. Now however, the state exchequer would have to bear the expenses that result out of these and it will be more than enough reason for policy makers to wake up and take notice. And with 79 million patients suffering from rare diseases in India, this potential amount is no small sum. In setting this precedent, the court has not only solved the problems of one particular child but has created far reaching ripples in other spheres of IP policy as well. Therefore, while the court acknowledges that it will not step into the domain of the Executive to make policies or the Legislature to make laws, by tying the exchequer to the effects of a weak IP policy or innovation model the court is in effect compelling them to act. Furthermore, it is likely that the presence of attempts towards addressing these rare disease needs through appropriate legislations may prove to offset the judiciary’s demands on the State to pay for treatment in individual cases such as the present one.

At a time when the Indian IP regime is under a lot of criticism for its allegedly poor patent protection, the modalities to achieve this need serious consideration. There is also the further question of whether the interpretation of Article 21 in this decision will be used in deciding whether compulsory licenses will be viewed more favourably in future cases.

This decision ought to also encourage the promotion of schemes such as the OSDD which served as a platform for the exchange of ideas between students, academics, researchers etc. which would help spur innovation. Decisions such as this would emphasise that in the presence of (cheaper) models of innovations such as the OSDD which the state can invest in, every effort should be made to promote them rather than to subdue them, the penalty for the latter being high costs of inaccessibility to the patients as well as to the State funds.

Considering the size of the patient consumer base of patients with rare diseases, patent protection might not be the problem in the first place. In response to the situation where a “non-generic” or innovator treatment for rare diseases is exorbitantly priced (to recover the high costs associated with R&D), the immediate answer that jumps to one’s mind is that of tailoring policies towards generic, cheaper drugs. However, this isn’t that simple. Given that most rare diseases are genetic, treatments tend to be biologic in nature and thus fairly expensive to manufacture, even for generics. Also, if generic makers are allowed or encouraged in the market for rare diseases, it divides the already miniscule consumer base, thereby reducing the original incentive to innovate or even to copy, which then spirals into a complete failure of the model. Therefore, a delicate balance needs to be maintained between these two kinds of drug manufacturers in order to ensure that some innovation takes place.

Questions of access never have, and never will be purely either IP or Constitutional Law issues. They are inextricably linked to each other. Decisions such as this, infuse a rights based approach in the IP regime in order to restore and maintain a fine balance between the interests of corporations and the public.

Many thanks to Swaraj for his help on this!

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Thomas J. Vallianeth

Thomas is a final year law student at the National Law University, Jodhpur pursuing a B.Sc. LL.B. (IP Hons.) course. His first exposure to IP law was at a workshop that he attended in High School and ever since then, he has pursued a keen interest in the field. However, his real interests lie in the interfaces between Technology Law and IP, with an active interest in the Open Source movement.

5 comments.

  1. AvatarThomas J. Vallianeth Post author

    Thank you Gautam! Although most of the credit is due to Swaraj 🙂
    And thank you for the references.

    Reply
  2. AvatarGautam

    Thinking a bit more about this – I suppose there are two ways in which IP can be constitutionalised. One is to invoke the right to health to require the *government* to provide access to medicine, *while* respecting the traditional IP regime – which is what Justice Manmohan SIngh has done in this case. It doesn’t change anything w.r.t. IP law, and places the burden upon the government to spend money to achieve certain constitutionally-mandated outcomes. Or, in other words, government pays for IP.

    The other is to invoke the right to *modify* the regime itself – e.g., for instance, use the right to health to expansively read S. 3(d). I suppose the hope is that with cases like these, it’s possible that the former approach will spill over into the latter.

    Reply
    1. AvatarThomas J. Vallianeth Post author

      Indeed Gautam! The observation that we were making in the post is that the former method would perhaps be “unattractive” to policy makers as it would impose quite avoidable costs on the exchequer.
      More conversation therefore needs to happen in policy circles regarding the latter approach.
      Thank you for your comment!

      Reply
  3. AvatarS Madhu

    Actually given budgetary constraints, the reality is that this judgement essentially asks the Govt. to increase the ambit of compulsory licensing. In cases like these, it is better for Govt. funded R&D (using a cost + model) to incentivize local drug companies to create drugs for rare diseases rather than adopting a pure private sector approach. But an audit of these drug costs are also necessary. It cannot be accepted as a truism that newer therapies are necessarily exorbitant in cost because of high R&D costs. Without transparency such claims are meaningless.

    Even in generics, I did a quick check on prices. Bulk cost of pantoprazole was about 7ps for a 40mg tablet. Retail is anywhere between Rs 1.8 to Rs 7. per tablet. 100x for wholesale to retail conversion ? This was about a year ago, differential is bit down but still not justifiable. Similar analysis can be done on another scam – heart stents. The list goes on.
    It is evident that more price control is the answer. If there are howls of protest against this, let independent audits justify the prices.

    I have toyed with the idea of disease sufferers forming a non profit cooperative to manufacture their own drugs, purely for self consumption. I wonder if protection against patents can be claimed under Article 21 ?

    Reply

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