DIPP Drags the Dasatinib Compulsory License Drama: A situation of “extreme urgency”?

image-1As our readers may recall, in January 2013, the Ministry of Health and Family Welfare (MoH) had recommended that DIPP declare that a compulsory license (CL) should be granted, under section 92 of the Patents Act, 1970, for three exorbitantly priced anti-cancer drugs – Bristol-Myers Squibb’s Dasatinib (or Sprycel) and Ixabepilone (or Ixempra) and Roche’s Trastuzumab (or Herceptin). Two of these three cases were dropped as Roche allowed its patent on Herceptin to lapse (presumably to avoid the license) and MoH raised safety concerns regarding Ixabepilone.  Regarding Dasatinib (used for treatment of chronic myelogenous leukemia or CML), DIPP had asked a series of questions to MoH including whether the probability of 0.001% occurrence of CML with no alarming increase could be categorised as national emergency or extreme urgency under section 92. In May 2015, MoH sent its point wise reply stating, among other things, that since Dasatanib was required by 40% of all CML cases, it certainly constituted a situation of ‘extreme urgency’. More than a year has elapsed since then, but it seems that the DIPP is yet to decide on the matter.

For more background on the matter, please read our posts here, here, here and here.

Trajectory of CL recommendation: RTIs, delays and inaction  

Earlier this month, we had brought to light that about 27 RTIs were filed by Mr. Pradeep Kumar from Delhi before the DIPP seeking status of Cipla’s revocation plea for Novartis’ Onbrez patents. Mr. Kumar also filed over 28 RTIs to DIPP following up on MoH’s recommendation for grant of CL for Dasatinib. Since only the RTI replies sent by DIPP in or after October 2014 could be found on the DIPP website, the entire trajectory of the matter could not be culled out. However, what could be gathered is noted below:

  • January, 2013 – MoH sent its recommendation to DIPP
  • June 16, 2014 – MoH sent a memorandum to DIPP
  • October 11, 2014 – DIPP sought more information from MoH in a 9 question letter including information on the total cost that government incurs on procurement of Dasatinib
  • March 11, 2015 – DIPP  sent a reminder to MoH
  • May 6, 2015 – MoH sent its point wise reply to DIPP stating, among other things, that a drug required by 40% of all CML cases is certainly a situation of extreme urgency
  • Till August 16, 2016 at least – DIPP said that the matter is under process and has not been finalized

No action seems to have been taken till date.

Questions raised

This raises questions similar to those raised by the manner in which the Cipla’s revocation request was handled by the DIPP:

  • Why has DIPP not been able to decide on the matter even after more than 3 years have lapsed since the MoH made the recommendation?
  • Why has it not conducted any meeting etc. till now to discuss the matter?
  • Shouldn’t such decisions that may have a huge impact on public health be taken at the earliest?
  • Shouldn’t there be a time limit imposed on the Central Government for taking such decisions?
  • Why did MoH take more than 6 months to send its reply to the questions asked by DIPP?
  • Shouldn’t all the documents pertaining to the matter like recommendation by MoH, questions asked by DIPP, MoH’s reply to them etc. be uploaded on the website for public viewing?

Health Ministry’s answers to DIPP’s questions: A good case for CL?

MoH in its reply to the DIPP’s letter clarified that Dasatinib is a second line treatment for CML while the first is Imatinib. Dasatinib is prescribed only to those CML patients who are resistant to Imatinib or become resistant to it during the course of the treatment. Such patients constitute approximately 40% of all CML cases. It further noted that although Dasatinib is not a cure for CML, the way most drugs are not for any type of cancer, it can increase life expectancy by 10 years or more and at a minimum by 3 years in at least 80% of the CML patients to whom it is prescribed. Further, the Ministry informed that Dasatinib is required by 6000 new patients each year but did not confirm the total number of cancer and specifically CML patients as queried by DIPP. It brought to light the disturbing fact that only 100-200 i.e. 2% of the total number of CML patients who require Dasatinib are able to access it at the current price. To the very pertinent question asked by the DIPP that whether the situation of 0.001% probability of occurrence of CML with no alarming trend in incidence could be categorized as that of national emergency or extreme urgency, MoH did not give a direct answer. Instead it stated that “a drug required by 40% of all CML cases is certainly a situation of extreme urgency”.

Is this argument by MoH convincing? Can a situation of extreme urgency be determined on the basis of the percentage of CML patients who require Dasatinib? Or should the determinant be the percentage of Indians or cancer patients who require Dasatinib? Or should it be the percentage of CML patients that require Dasatinib but can’t afford it? MoH has mentioned in its reply that only 2% of the Dasatinib demand is met at the current price i.e. 98% of the CML patients requiring Dasatinib can’t afford it. If its argument for extreme urgency was based on this data, then would it have been convincing? Should the fatality of a disease and unaffordable pricing of the patented drug required for its treatment be sufficient for invoking the ground of ‘extreme urgency’? Or should the magnitude of the disease prevalence and/or the disease type i.e. infectious or chronic also matter? In short, how should the scope and ambit of the ambiguous terms ‘extreme urgency’ and ‘national emergency’ be really defined? Will any disease qualify so long as some people are shown to have not access to the drug required for its treatment? Also, what is the difference between the terms ‘extreme urgency’ and ‘national emergency’? Or are they the same and substitutable? If anyone has access to any literature or case law that sheds light on this, please do share with us, and we can run another post with those inputs.

In any case ‘extreme urgency’ and ‘national emergency’ are not the only grounds for CL under section 92. A CL may also be issued in case of a ‘public non-commercial use’. This less ambiguously worded ground, as explained in our earlier post, “is of potentially wide ambit and simply requires at a bare minimum that the government does not make a profit on the use of the patent”. MoH was reported to have argued for a CL on this ground also, stating that the public institutions could procure only a small quantity of Dasatinib owing to its high price and that a CL would allow them to acquire the drug at a much lower cost. From its reply to DIPP’s questions regarding total cost etc. of government procurement of Dasatinib, MoH seems to maintain the argument for CL on the ‘public non-commercial use’ ground as well. It provided DIPP with the information on the expenditure made on procuring the drug for CGHS beneficiaries in Delhi during 2011-14 and by the Ministry of Defence during 2011-13 and also the total value of import for 2011. The argument based on this clearer ground of ‘public non-commercial use’ could very well be found persuasive.

Is the basis for singling out three drugs for CL sound?

There is also a larger concern that the MoH’s recommendation for a CL under section 92 raises: Why was it made only for certain anti-cancer drugs? What about other patented drugs? The recommendation for the three drugs was stated to have been prompted by the exorbitant pricing of these drugs as a monthly dose of each of them cost more than Rs. 1 lac. But are only these drugs unaffordable? Can a CL be issued under section 92 on the basis of unaffordable pricing alone? Or if the reason was the sizeable number of patients who require these drugs in addition to them being unaffordable or something else, aren’t there other drugs that fall within that category? Or is it that the lobbying pressure from the stakeholder companies has a role to play in this?

DIPP’s decision awaited

One can only hope that DIPP will take the Dasatinib CL decision at the earliest and query the MoH further, if need be. And that it will take a final decision based solely on the basis of the merit of the case and uninfluenced by any extraneous factors.

Curious case of Ixabepilone

Apart from Dasatinib, as mentioned before, CL recommendation was made by MoH for two other anti-cancer drugs, Trastuzumab and Ixabepilone, as well. The recommendation for Trastuzumab was not pursued further because the patent for it was allowed to be lapsed by Roche. But the case for Ixabepilone was dropped because it was found to be unsafe by MoH as seemingly first mentioned in a news report dated September 11, 2013 and later by Commerce Minister Nirmala Sitharaman in her written reply in Lok Sabha dated December 19, 2014  (In Europe also, a negative opinion was given on the drug by the Committee for Medicinal Products for Human Use, consequent to which BMS had withdrawn its application for marketing authorization in 2009). However, on August 2, 2013, the New Drug Advisory Committee (NDAC) (Oncology and Hematology) had recommended continuation of marketing of Ixabepilone. Nevertheless, if safety concerns were concluded to exist, was the regulatory approval granted for this drug revoked? Or did BMS withdraw the drug from the Indian market? If not, and this patented drug continues to be sold in the market, then why has the CL recommendation for it not been taken forward?

Image from here

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