Indian Draft Pesticides Bill Contains TRIPS-Plus Data Exclusivity, Indian Pharma Says

India is considering legislation on pesticides containing data exclusivity provisions that would raise the level of intellectual property protection above the minimum required by international trade agreements and could act as a precursor for pharmaceutical products in the country, a leading Indian industry representative warned this week. India is sensitive to restrictions on the use of marketing data of patented pharmaceuticals as it is seen as the world leader in generic medicines, which use such data.

According to Dilip Shah, secretary-general of the Indian Pharmaceutical Alliance, India is considering the introduction of a so-called “Pesticides (Amendment) Bill.” The bill, which is expected to be submitted to the Parliament when the Budget session resumes after 20 April, according to Shah, proposes to introduce five-year data exclusivity for agro-chemicals and pesticides. This would render those products unaffordable for farmers, he asserted.

A representative of multinational agro-producers in India, meanwhile, disagreed with the concern.

The introduction of data exclusivity comes as a response to the push from multinational corporations (MNCs), which have been asking for data exclusivity for agro-chemicals and pharmaceuticals, Shah stated in an explanatory note [pdf]. The pesticides bill itself is not yet publicly available.

If data exclusivity is awarded to agro-chemicals, India would find it difficult to deny the same advantage to pharmaceuticals, he said, making medicines unaffordable to patients.

According to Shah, the Indian Union Cabinet approved five-year data exclusivity for agro-chemicals and pesticides. This will now be incorporated into the draft bill, Shah told Intellectual Property Watch.

Currently, drug regulatory authorities require the first applicant to submit data on safety and efficacy of a new drug or a new agro-chemical substance, Shah’s note said. Subsequent applicants are not required to duplicate this data, which involve substantial costs, but need to establish the equivalence to the approved products.

The World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires that the government protect the data from unfair commercial use by competitors, Shah said. However, “reliance on this data by the regulator for approval of subsequent applicants is not unfair commercial use,” he said in the document.

There is no requirement in the TRIPS agreement for data exclusivity. The proposed data exclusivity would result in market exclusivity, extending legal monopoly, he said.

TRIPS Article 39 deals with the protection of undisclosed information. Article 39.3 states that “Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.”

Shah noted that data exclusivity can be granted whether the product is patented or not and is in addition to the period of exclusivity granted under the patent. Data exclusivity cannot be challenged or invalidated. The introduction of data exclusivity would delay the entry of affordable generic products, he added.

In 2008, a bill in India providing for three years data exclusivity was withdrawn. The same year, the 88th report [pdf] by the Committee on Ministry of Commerce and Industry, which is responsible for India’s IP regime, was issued, Shah told Intellectual Property Watch. The 2008 bill was presented by the Ministry of Agriculture, and “was withdrawn by the government for further amendment as it remained pending for a long time,” he said.

The 88^th report warned against the push from “certain Multinational corporations” to introduce data exclusivity. The committee said they “were informed that the MNCs are demanding ‘Data Exclusivity’ on their data, so that its use could be prevented for allowing generic manufacturers to take marketing approval.”

“The Committee is aware of the fact there is considerable pressure on the Government to accede to this demand,” the report said. “The Committee feel that conceding to demand for Data Exclusivity would amount to agreeing to TRIPS plus provisions.”

The committee expressed concerned about potential further consequences. “Data Exclusivity may result in delay in ensuring role of domestic enterprises through compulsory licensing system, and in preventing other parties from developing similar data,” the report said.

“Since the consequences of Data Exclusivity are quite serious, the Committee strongly recommend that the Government should not fall prey to such demands of MNCs. The Government must thwart such attempts, being made at the behest of certain vested interests,” it added.

According to Shah, civil society, opposition parliament members and farmers’ organisations are all challenging the new bill.

Concerns Unfounded, Says Former Crop Life Director

Uttam Gupta, former executive director at Crop Life India and former additional director with Fertilizer Association of India, wrote in a blog that “the concern raised by domestic industry that this [bill] will delay launch of generics/copycats is untenable.” Crop Life represents multinational agriculture companies.

“The very rationale of granting DE [data exclusivity] is to delay entry of ‘me too’ [products] so that a company which has invested heavily in generating data gets a chance to recover expenses and also gear farmers to proper use through ‘stewardship’.”

Gupta said that the proposal to grant data exclusivity for agrochemicals for a period of 5 years “could be a precursor to grant of similar dispensation for pharmaceuticals.”

Data exclusivity is particularly relevant for old molecules that are launched in India, he said. “For new molecules any way, the much longer period of patent protection (20 years) will keep unfair competition from generics at bay.”

According to Gupta, “it is a misnomer to say that only MNCs stand to gain from [data exclusivity],” because “Domestic companies too can avail of the benefit provided they make efforts and get registration on the strength of their own data.”

“To enable farmer’s access to better and eco-friendly crop protection products to minimize losses, increase quality of agri-produce and give a boost to research and development, government should expedite passage of PMB [Pesticides Management Bill] with 5 years [data exclusivity] from date of registration in India,” he said. “This will also improve India’s perception about our compliance with TRIPs agreement of WTO.”