19 Apr, 2013, 04.52AM IST,
India is now in the position of a thought leader on pharmaceutical patents.
But the country cannot afford to lose the moral high ground.
Weeks after the Supreme Court ruling on Novartis AG's cancer drug, Glivec, one thing is clear: India is now in the position of a thought leader on pharmaceutical patents. But the country cannot afford to lose the moral high ground.
Therefore, just as India has set the bar on repetitive patenting, it cannot be seen as being guilty of condoning patent law violations. India should ensure that it does not violate any multilateral trade agreements when invoking tools like compulsory licensing for ensuring affordability of patented innovator drugs.
Moreover, the judicial system should also be alert to local generic drug makers trying to exploit loopholes in existing regulations to bring their products into the market in flagrant violation of the spirit of these rules.
Already, large overseas pharma innovators are threatening to reduce their investment on drug research and development in India following multiple concerns that include the Glivec ruling, the spate of compulsory licensing cases as well as the recent Merck vs Glenmark case on a patented diabetes drug.
There could be a freezing effect on the entry of cuttingedge pharma products from overseas innovators into India, which will deprive patients here access to the most recent medical advances.
A competitive cost base and a strong scientific talent pool have helped India emerge as a preferred innovation partner for contract research and clinical development services for large pharma innovators.
But a weak IP regime could push these companies away from doing business with local players. We simply cannot afford to lose our competitive position as a preferred destination for innovation.
To prevent lasting damage to its image of an investment-friendly destination, India needs to move quickly to demonstrate that it is a credible signatory of the TRIPS agreement and takes its obligations on intellectual property rights seriously.
So, if a large pharma innovator makes a strong case of its patent rights being compromised, India should move to redress it quickly. The government will also have to base its decisions on patent issues on evidence-based data and not be compelled by activists' pressure.
Laws should also be strengthened to make patent prosecution severe enough to deter future violations. Let's be very clear: India needs patented drugs. We should be mindful of spurious arguments in certain media reports against the need of a strict IP regime in India, considering only 1% of the domestic pharma market comprises patented drugs.
One must understand that it is through these patented drugs that Indians can access treatments for unmet medical needs. And this access does not come cheap, there is a big difference between the cost of innovation vis-avis the cost of imitation. This begs the question: who should pay for the high cost of drug innovation?
It is an important question in India, where affordable health care is a critical issue and requires the government to play a much bigger role. However, the government seems to have abdicated its responsibility in this regard.
In such a scenario, regulatory authorities need to define a smarter regulatory pathway that cuts the cost of development and enables affordable drug innovation, benefiting consumers by improving access to affordable drugs.
For example, drugs that have already obtained approval from the US or European drug regulator, should be granted a waiver on conducting clinical trials in India. The regulator should give such drugs a "conditional approval" and give them a year's time to collect "safety and efficacy" data post marketing.
The final approval should be given after submission of this data. This will ensure that local regulatory requirements don't add to the cost of innovation, forcing innovator companies to price their products at a premium.
Smart regulations and a strong patents regime can help India build an ecosystem that fosters cheaper drug innovation and gives pharma innovators the impetus to pass on the benefits to patients, without having to take a hit to their bottom lines.
India needs inventive solutions to meet the health care needs of millions through affordable medicines. But affordability and access can't come at the cost of disrespecting IP rights.
India must clearly enunciate the rules governing patentability, demonstrating their compatibility with the TRIPS agreement. Such a move is crucial as pending judgments on various patent cases will be closely watched by the world to determine where India stands on the key issue of intellectual property rights.