Blogging is about being human and connecting in a very real way. You have seen me (Duncan) rant from time to time on this blog.
Now, over to you Vandana…
The review
The Department of Industrial Policy and Promotion (DIPP) has recently reviewed the provisions related to the compulsory licensing. This is yet another attempt by the Indian Government to tackle the issue of Access to medications.
What’s missing?
While it is well understood that the report aims at striking a balance between the access issue and patent protection, what seems to be missing is a holistic approach to a problem that has a multi-pronged origin. The primary question here would be – is Access to medication is merely a Patent Issue? In a country with a vast geography and the social-economical condition as that of India, many factors in reality contribute to the access issue. This may include poor infrastructure, inaccessible terrains, huge population, illiteracy, security issues including social, economical security, internal and external threats, a less developed health insurance industry etc. Notwithstanding the extra burden that patent rights have added to the governments in resolving the access issue, it still remains that patents should be regarded only one component of the issue and not the issue itself.
It’s not just pricing
Monopolistic pricing definitely is a concern and innovators might need to look at a differential pricing strategy for developing and under developed nations. Generic pricing on the other hand does ensure costs at a fraction of the innovators but this again does not resolve the access problem. For instance, pricing a drug at 1/10th of the innovator may not bring the costs in an ‘affordable range’ at all. There is obviously a need to establish what affordable costs really are. This doesn’t imply disregarding reasonable costs but indicates a need for external funding perhaps by governmental organizations to bridge the gap between reasonable and affordable costs.
Compulsory licenses are not a panacea
Even if the drugs were to be distributed for free, there is no reason to believe that a new drug under compulsory license will be accessed by a part of the patient population which is unable to have access to already existing old analogues. Merely granting Compulsory licenses without building up the health infrastructure will hardly aid in resolving the access issue.
Another matter that is often overlooked is the lack of guidance to determine the category drugs for which access is a problem. For example, is compulsory license required if off-patented drugs for treatment are available at affordable costs?
In summary, Compulsory licensing in itself may not provide a solution to the access problem. A concerted approach bringing together other issues like public health and distribution systems, enforcement measures, Health insurance etc. may provide some insight in resolving the problem. On a futuristic note, what needs to be looked into is increasing the purchasing capacity of the population rather than decreasing drug costs.
[Image credit: alles-schlumpf]
The Department of Industrial Policy and Promotion (DIPP) has recently reviewed the provisions related to the compulsory licensing. This is yet another attempt by the Indian Government to tackle the issue of Access to medications.
While it is well understood that the report aims at striking a balance between the access issue and patent protection, what seems to be missing is a holistic approach to a problem that has a multi-pronged origin. The primary question here would be – is Access to medication is merely a Patent Issue? In a country with a vast geography and the social-economical condition as that of India, many factors in reality contribute to the access issue. This may include poor infrastructure, inaccessible terrains, huge population, illiteracy, security issues including social, economical security, internal and external threats, a less developed health insurance industry etc. Notwithstanding the extra burden that patent rights have added to the governments in resolving the access issue, it still remains that patents should be regarded only one component of the issue and not the issue itself.
Monopolistic pricing definitely is a concern and innovators might need to look at a differential pricing strategy for developing and under developed nations. Generic pricing on the other hand does ensure costs at a fraction of the innovators but this again does not resolve the access problem. For instance, pricing a drug at 1/10th of the innovator may not bring the costs in an ‘affordable range’ at all. There is obviously a need to establish what affordable costs really are. This doesn’t imply disregarding reasonable costs but indicates a need for external funding perhaps by governmental organizations to bridge the gap between reasonable and affordable costs.
Even if the drugs were to be distributed for free, there is no reason to believe that a new drug under compulsory license will be accessed by a part of the patient population which is unable to have access to already existing old analogues. Merely granting Compulsory licenses without building up the health infrastructure will hardly aid in resolving the access issue.
Another matter that is often overlooked is the lack of guidance to determine the category drugs for which access is a problem. For example, is compulsory license required if off-patented drugs for treatment are available at affordable costs?
In summary, Compulsory licensing in itself may not provide a solution to the access problem. A concerted approach bringing together other issues like public health and distribution systems, enforcement measures, Health insurance etc. may provide some insight in resolving the problem. On a futuristic note, what needs to be looked into is increasing the purchasing capacity of the population rather than decreasing drug costs.