Impact of the National IPR Policy on Access to Medicines

Question by Priyanka Sunjay.

Jurisdiction – India

Two articles posted on The Hindu take different positions on the impact that the National IPR Policy would have on access to medicines. One article argues that the IPR Policy could impede access to affordable drugs, whereas the other states that the Policy protects public interest by ensuring access to drugs at affordable prices. This post explains the actual impact that the Policy is likely to have on access to medicines.

Commitment to Doha Declaration

The Policy notes in its Mission Statement that it aims to enhance access to healthcare. This statement is substantiated through Objective 3 (Legal and Legislative Framework) wherein it states that India will maintain its commitment to the Doha Declaration on TRIPS Agreement and Public Health.[1] The Doha Declaration stresses upon the need to interpret and implement the TRIPS Agreement in a manner that protects public health. India’s commitment to the Declaration is a promising display of its intention to provide affordable healthcare to the public. This is especially significant in the light of several countries refusing to reaffirm the Doha Mandates during the WTO’s 10th Ministerial Conference held at Nairobi in 2015 (more on this here).

According to Leena Menghaney of Médecins Sans Frontières (MSF), the Policy fails to explain how the commitment to the Declaration will translate to reality (as cited here). “There is no clarity in the section pertaining to commitment to Doha Declaration,” she argues.

The Policy, however, provides several broad action-points that would translate the commitment into concrete results – such as encouraging research and development, taking measures against attempts to treat generic drugs as spurious or counterfeit and continuing use of TRIPS flexibilities to protect public health. Hence there is little to suggest that the Policy’s commitment to the Declaration is inadequate.

Compulsory Licensing

Objective 3 also makes it clear that India will continue to utilize the flexibilities provided under the TRIPS Agreement and other international treaties. Perhaps the most important of these flexibilities is compulsory licensing which allows cheaper generics to be manufactured and sold when a patented drug is expensive or unable to meet the requirements of the public. The Policy’s affirmation to continue using such flexibilities was much needed after reports were leaked of India giving private assurances to the US that it would not grant compulsory licenses for commercial purposes. The Policy, on the face of it, puts these concerns to rest.

However, it remains to be seen if the government will act upon the Policy or maintain a concealed stand against compulsory licensing.

Section 3(d)

Section 3(d) of the Patent Act, 1970, prohibits grant of patents for chemical forms that do not increase the efficacy of the compound. Thus it prevents ‘evergreening’ of patents.[2] Evergreening has a detrimental impact on access to medicines because it allows patents for even slight chemical modifications of existing drugs. In Novartis v. Union of India,[3] section 3(d) was the basis on which evergreening of the drug Glivec was prevented.

This provision, however, has been severely criticized by the US and has led to India being classified as a Priority Watch-List Country under the Special 301 Report. Despite being attacked by the US, this section has been retained under the Policy. The Policy clearly states – “The existing laws were either enacted or revised after the TRIPS Agreement and are fully compliant with it.” Preventing evergreening is in public interest since it ensures that pharmaceutical patents are not extended for trivial modifications.

Conclusion

The Policy certainly retains access to affordable medicines. It displays confidence in India’s patent law which include several provisions that promote access to medicines such as compulsory licensing, Bolar exemption[4] and parallel importation.[5] The stand so taken is pro-healthcare.

The actual concern is the extent to which the government will act upon the Policy. Ms. Menghaney voices this concern when she questions the point of retaining compulsory licensing when such licenses are almost never granted. As Prof. Shamnad Basheer argues, the Policy rehashes the polemic about balancing public health with intellectual property. In doing so, it misses the opportunity to do more – to address problems such as promoting healthcare for neglected diseases and treating IP as means to a goal instead of a goal in itself.

Additional reading

This article by Prof. Basheer holistically discusses the shortcomings with the Policy.

Image from here.

[1] Doha Declaration available at https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm.

[2] As was noted in Novartis v. Union of India (2013) – Evergreening is a practice “wherein a trifling change is made to an existing product, and claimed as a new invention. The coverage/protection afforded by the alleged new invention is then used to extend the patentee’s exclusive rights over the product, preventing competition.”

[3] (2013) 6 SCC 1.

[4] Section 107A(a) allows for reverse engineering and creation of bio-equivalents of patented drugs for submitting data to gain regulatory approval.

[5] Section 107A(b) provides for international exhaustion. Hence patented drugs can be imported from other countries and sold in India at cheaper prices.

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s