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| Edited By: Priyanka Golikeri |Source: DNA |Updated: Mar 30, 2018, 03:43 AM IST
India’s coveted perch as the top supplier of generic medicines is under threat.
The European Union, Japan, the United States, Canada as well as developing nations such as Mexico have nearly concluded an agreement that could seriously undermine the country’s ability to supply low-cost off-patent medicines to the world’s poor.
Indeed, should the Anti-Counterfeiting Trade Agreement (ACTA), the draft text of which was released this week, pass muster, violations of intellectual property (IP) will become a criminal offence in those countries.
Going by industry experts, the agreement permits seizure and destruction of generic medicines on the mere assumption that they look similar to the innovator product.
“Generic companies may even face criminal proceedings merely on the basis of an allegation of infringing a patent or trademark,” said a Mumbai-based IP expert.
A lawyer working in the area of access to medicines explained the likely difficulties for an exporter: “Say a generic AIDS medicine by X company in India has been shipped to a patient in Mexico by a patient group. Now if someone alleges that this AIDS medicine violates either trademark or patent of the innovator product, then along with the X company, the patient group and the patient can get pulled to court.”
“They can face severe penalty and imprisonment,” said Dr Unni Karunakara, international council president, Medecins Sans Frontieres, an international humanitarian organisation, which buys over 80% of its AIDS medicines and 25% of its antibiotics and TB/malaria medicines from India for supply in poor countries.
“This reduces the viability of generic production as companies will feel threatened to manufacture and supply generics,” said a Mumbai-based IP expert.
Those manufacturing generic medicines will be hit hard for sure.
But it would be a harder blow for poor people the world over who depend on medicine supplies from India as they cannot afford the exorbitantly priced medicines sold by innovator MNCs.
“The agreement can severely affect supply of low-cost generics from
India and keep several poor patients who can’t afford expensive innovator medicines without treatment,” said the lawyer.
As per the Journal of International AIDS Society, between 2002 and 2008, over 4 million people in sub-Saharan Africa and Latin America were treated with low-cost HIV/AIDS medicines made in India.
According to DG Shah, secretary general of Indian Pharmaceutical Alliance, ACTA is a much more serious issue than the seizure of more than 17 consignments of legitimate Indian generic medicines by customs officials in The Netherlands and Germany last year. Yet, “India can’t do anything now except indicate its displeasure.”
Experts see ACTA protecting the commercial interests of companies at the cost of the patients.
“Instead, action against unsafe medicines should be developed through a legitimate process involving all countries and not just among a few countries negotiating in secret,” said Dr Karunakara.
