-By Ashwani Mahajan
Since the time of GATT (General Agreement on Trade and Tariff) negotiations, the issue of the data exclusivity has been a bone of contention. There had been a consistent effort and lobbying by the multinational corporations to include data exclusivity in the rule book, in one way or the other. But the nation had been able to thwart their efforts in this regard. When in the first instance, a bill was proposed to amend Indian Patent Act, 1970 after TRIPS agreement in WTO, the clause of data exclusivity was opposed by the people at large, and parliamentarians and experts in particular, who were aware of its implications; and that clause was done away with, and various other provisions were included in Indian Patent Act, 1970 (Amendment) to safeguard the interest of the people in view of the public health, protection of farmers and industry by allowing compulsory licensing among others.
Data exclusivity, is not a new term, but it has been gaining currency recently. We understand that patent (a form of Intellectual Property Right), grants exclusive right to patent holder for marketing and enjoying monopoly and royalty, if the rights are transferred to other parties. Though, data exclusivity and patents are two different concepts, but if we go into the details, data exclusivity in effect extends the monopoly rights of the patent holders, beyond the period of patent protection.
What is Data exclusivity?
“period of time during which an applicant cannot rely on the data in support of another marketing authorization for the purposes of submitting an application, obtaining marketing authorization or placing the product on the market, i.e.: generics, hybrids, biosimilars cannot be validated by the Agency.”
We see, if provision of data exclusivity is introduced, then those manufacturers, awaiting to start production of items, after the expiry of patents, will not be able to do so, till the period of data protection or data exclusivity is not over. It’s seen that India, and its industry has been greatly benefitted by producing generic products, reducing the prices of pharmaceuticals significantly, sometimes, even to the extent of 90 to 95 percent. Data exclusivity is directly linked with blocking and delaying, the efforts of Indian industry willing and waiting to manufacture generic products to make it available at affordable prices to the user, consumers, farmers and industry.
Renewed Attempts to bring Data Exclusivity
Though, official stated stand of the government has been clear beyond doubt, that it has no intention to allow data exclusivity, in any form, the efforts by MNC and foreign governments have been continuing consistently all these years. Though, for more than two decades, these efforts failed to garner much headway, recently there have been some renewed efforts to include data exclusivity by way of Free Trade Agreements (FTAs). This issue of allowing Data Exclusivity, though, is on table of negotiations, is being opposed by Indian side. Unfortunately, some unsolicited attempts are also being witnessed, in some quarters in the government, which is a cause of greater worries. One such effort is by way of an order, dated November 4, 2024, by Department of Agriculture and Farmer Welfare, Plant Protection Division. As per this order a committee has been constituted to explore and examine the provisions related to data protection for agrochemicals. This order, has been issued on the pretext, ‘ to study the requirements of regulatory data protection and global best practices on data protection with the intent to introduce new molecules and pesticides that have no alternatives aimed at protecting major crops from these losses due to new invasive pests and diseases’.
In 2019, India walked out of a mega FTA, called RCEP, where proposed provisions sought to extend pharmaceutical corporations’ patent terms beyond the usual 20 years and also would require data exclusivity that limits competition. Data exclusivity and extending patent beyond 20 years and other provisions were a cause for great concern with respect to public health, because of their potential adverse impact on access to affordable medicines.
In many of the FTAs on table, including UK, USA and EU, this issue of data exclusivity is definitely, a cause of major concern for Indian industry, especially pharmaceutical and chemicals.
Official position so far
On the issue of data exclusivity, the official position is reflected by way of various office memorandums including the one issued on September 1, 2015, with regard to proposed Pesticide Management Bill. The office memorandum states that the provision of data exclusivity for five years as proposed in the Pesticide Management Bill is TRIPS plus, and in case this provision is extended to agro-chemicals, there will be pressure from MNCs to extend the same to pharmaceutical products also. The order, further states that that exclusivity in pharmaceuticals will not only delay entry of generics by creating additional period of legal monopoly, but will also make medicines unaffordable to patients.
Parliamentary Committee Report December 2021 on PMB 2020:
Parliamentary Committee after taking due consideration of all the earlier committee reports and facts on Data protection / exclusivity and also all stakeholders views into consideration, conclusively recommended that, No data protection be given beyond patent period, as patent period of 20 years is sufficient for inventors to gain benefits. ‘No Provision’ of Data Protection for the introduction of New Molecules/ Products, will protect the domestic industry and also the Indian farmers will be benefitted by the availability of cheaper pesticides.
If data protection/ exclusivity is allowed?
Provision of data protection is fraught with major negative consequences, which our nation cannot afford. Let’s see how the absence of a data protection has benefited people and domestic manufacturers, and economy at large and if we heed to the lobbying of MNCs and foreign governments, what are the negative consequences:
We know that moment patent expires, domestic pharmaceutical manufacturers are able to start manufacturing the product. We see that the price of product comes down by up to 90 percent, making it much more affordable to the consumers. We know that generic drugs are available at nearly 90 percent discount through PM Jan Aushadhi Kendras, being run under government scheme; and this has been made possible due to the fact that data protection is not allowed to the patent holders, beyond the period of patent. If we allow data protection, then this benefit will vanish and consumers will be forced to pay much higher prices for medicines and other health products, and most of the people will be deprived of the medicines. A country, with prevalence of low incomes, can ill afford this kind of situation.
It’s not just pharmaceuticals and other medical products, prices of agro-chemicals are also reduced significantly, with domestic production after the expiry of patents. For instance, price of Acetamiprid 20%SP fell from Rs 6380 per Kg to only Rs 800 per Kg (87 percent decline). Similarly, we see that all erstwhile patented molecules, which are now being produced in India are priced lower between 60 percent and 90 percent.
If we allow data protection beyond patent period, there is also a danger that the product may vanish from the market, or the same is not introduced, if the same was not being produce till date. Order of Ministry of Agriculture and Farmers Welfare (MOAFW) also says that there are many molecules, patents of which have expired, are not being produced. Now these molecules of can easily be introduced, if the data protection is absent.
Recently, there has been yet another attempt by the patent holders of biological medicines to block the generic versions (bio-similars), by extending their patents internationally. However, in India Article 3(d), doesn’t allow evergreening of patents. But if provision of data protection is made, it can delay availability of bio-similars, which are generic versions of biologicals. Delay or non availability of bio-similars can deprive people with incurable diseases, from affordable treatment.
