India -- a nation known for its innovation in many areas -- has decided that incremental innovation in pharmaceuticals isn't important -- at least when it comes to patent protection.
In an interesting and important new paper, Trevor Jones (a member of the WHO's Commission on Intellectual Property Rights, Innovation and Public Health) points out that a new Indian law contains a clause (Clause 3D) that restricts innovation through incremental advances.
Here's a link to the complete paper:
http://www.law.gwu.edu/NR/rdonlyres/B1AA54BE-46F2-4203-964C-0430248BA36B/0/InnovationattheCrossroads.pdf
In short, unless the new medicine can show "proven additional efficacy," patent protection can be denied under 3D.
Now, besides being a pretty obvious violation of TRIPS (27-1 -- coincidentally the same clause used to shut down compulsory licensing in Canada, but that's another story), it's another example of how healthcare technology assesment (HTA) aka: evidence-based medicine (EBM) is being used to deny not only appropriate patient care, but now case patent protection.
And the two are linked because if you don't get the patent protection, the innovator company can't earn back what it invested in R&D, ergo they can't reinvest their profits in further R&D -- further delaying crucial incremental innovation which is how medical progress is made.
There's another link between 3D and evidence-based (read "cost-based") medicine, and that's the reliance on RCTs as the comparative evidence used to make the decision as to patentability (in the case of Clause 3D) or patient care (in the case of organizations such as NICE).
This is as much a Developing World issue as a First World one. Relative to treatments for HIV/AIDS Jones writes,
"Some that are very similar in chemical compositions have been referred to as me-too products, but all the drugs have been vital to the pandemic ... In fact, we need more, not less, me-too products."
Before we deny care (or patents) to the new medicines that take us down the path of incremental innovation, let's remember that such economically-driven, short-term decisions can have deadly unintended consequences.
In an interesting and important new paper, Trevor Jones (a member of the WHO's Commission on Intellectual Property Rights, Innovation and Public Health) points out that a new Indian law contains a clause (Clause 3D) that restricts innovation through incremental advances.
Here's a link to the complete paper:
http://www.law.gwu.edu/NR/rdonlyres/B1AA54BE-46F2-4203-964C-0430248BA36B/0/InnovationattheCrossroads.pdf
In short, unless the new medicine can show "proven additional efficacy," patent protection can be denied under 3D.
Now, besides being a pretty obvious violation of TRIPS (27-1 -- coincidentally the same clause used to shut down compulsory licensing in Canada, but that's another story), it's another example of how healthcare technology assesment (HTA) aka: evidence-based medicine (EBM) is being used to deny not only appropriate patient care, but now case patent protection.
And the two are linked because if you don't get the patent protection, the innovator company can't earn back what it invested in R&D, ergo they can't reinvest their profits in further R&D -- further delaying crucial incremental innovation which is how medical progress is made.
There's another link between 3D and evidence-based (read "cost-based") medicine, and that's the reliance on RCTs as the comparative evidence used to make the decision as to patentability (in the case of Clause 3D) or patient care (in the case of organizations such as NICE).
This is as much a Developing World issue as a First World one. Relative to treatments for HIV/AIDS Jones writes,
"Some that are very similar in chemical compositions have been referred to as me-too products, but all the drugs have been vital to the pandemic ... In fact, we need more, not less, me-too products."
Before we deny care (or patents) to the new medicines that take us down the path of incremental innovation, let's remember that such economically-driven, short-term decisions can have deadly unintended consequences.
