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 The impact of the Trans-Pacific Partnership (TPP) struck last week
between 12 nations, which include the United States but not India,
is still being studied by Indian drug makers. But in initial
comments, industry executives said provisions in the deal that
shield new drug data from competitors would hurt their business in
those nations.
"The generics decline will be discernible from the end of 2017,"
said D.G. Shah, secretary general of an industry group representing
some of India's top drug makers, including Sun Pharmaceutical
Industries Ltd and Dr Reddy's Laboratories Ltd.
Countries from the United States to Africa rely on India as a
supplier of cheap medicines, earning it the "pharmacy to the world"
nickname.
Other critics of the TPP deal, including advocacy groups such as
Medecins Sans Frontieres, say it will drive up the price of
medicines around the world in the long term.
U.S. Democratic party presidential candidate Hillary Clinton weighed
in last week, warning the deal seemed to put the interests of big
U.S. drug companies ahead of patients.
Jagdish Bhagwati, a professor of economics and law at Columbia
University, considered one of the world’s leading trade economists,
said the deal was part of a trend to include trade-unrelated
features on labor and intellectual property into trade deals, at the
behest of U.S. lobbies.
"TPP is a model of such behavior and deplorable architecture," he
said.
The deal, a central tenet of U.S. President Barack Obama's focus on
Asia, is pending ratification by member countries and approval by
the U.S. Congress.
Under current global rules drug manufacturers can sell products they
develop exclusively for at least 20 years, after which generic
manufacturers can produce cheaper copies.
Citing details leaked by Wikileaks, as the text has not been
formally released, Shah said TPP sought to extend patent life, make
it easier to ‘evergreen’ patents, and abolish rules allowing generic
companies to undertake product development during the life of the
patent.
"These and many other provisions will delay the launch of generics
in the USA and other TPP member states,” said Shah, who heads the
Indian Pharmaceutical Alliance.
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BIOGEN FRONTIER
One focus of criticism is a clause in the deal that would allow
companies in member countries to keep clinical data on new
biological drugs hidden for up to eight years.
Since some TPP countries do not currently afford such protections,
the clause would effectively delay the launch of cheaper forms, or
biosimilars, of such drugs by other companies, said Judit Rius
Sanjuan, a legal policy adviser for MSF in New York.
Campaigners fear such provisions could become a global norm. Even
so, the clinical data clause was not as restrictive as the 12 years
the U.S. pharmaceutical industry wanted.
"There has been a push back from member countries, which has reduced
the data exclusivity period," said Kiran Mazumdar Shaw, chief of
India's biggest biotech firm Biocon Ltd.
"(This) should work to the advantage of Indian biopharma."
And Amitabh Kant, secretary of India's Department for Industrial
Policy and Promotion, said it was too early to say what impact the
deal would have on the Indian industry.
"(TPP) is a long-term process," Kant told Reuters, adding that India
was keen to reach an agreement on a regional trade pact with South
East Asia and China, and aspired to become a global pharmaceutical
manufacturing center.
(Additional reporting by Frank Jack Daniel and Manoj Kumar in New
Delhi; Editing by Will Waterman)
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