[Ip-health] Stat (PHARMALOT) A Canadian bill would make it easier to issue compulsory licenses for Covid-19 products
thiru at keionline.org
Thu Mar 26 04:11:40 PDT 2020
A Canadian bill would make it easier to issue compulsory licenses for
By ED SILVERMAN @Pharmalot
MARCH 25, 2020
In response to the pandemic, Canadian lawmakers have passed a bill that
would speed the process of issuing compulsory licenses for medical
products, adding to a list of countries seeking to ensure access to
medicines and devices, among other items.
A country may grant such a license to a public agency or a generic drug
maker, allowing it to copy a patented medicine without the consent of the
brand-name company that owns the patent. This right was memorialized in a
section of a World Trade Organization agreement known as the Trade-Related
Aspects of Intellectual Property Rights, or TRIPS.
Actually, Canadian law already permits the government to issue a compulsory
license, but the bill would essentially speed the process by allowing the
country to move much faster to secure a license in the event of a public
health crisis. Rather than the undergoing the usual process of haggling
with a company over terms, the government could simply issue a license and
negotiate compensation later (see part 12).
“What they’ve done is procedural but significant because a company won’t be
able to fight about a license upfront, which means the government can use
it immediately,” explained Richard Gold, a law professor at McGill
University in Montreal who focuses on life sciences and intellectual
property. “It’s signaling to everyone the government won’t put up with
delays if there’s a public health emergency.”
For now, he added, the move seems designed to ensure access to personal
protective equipment in situations where price gouging occurs or a company
is unable to handle orders. In such cases, the government could issue a
license to another company to make the products. The bill passed the Senate
and House of Commons and is awaiting the signature of Governor General of
Canada Julie Payette.
A spokeswoman for Innovative Medicines Canada wrote us that the trade
group, which represents brand-name drug makers, is still reviewing the bill
and does not have a comment. As for generic companies, the Canadian Generic
Pharmaceutical Association, not surprisingly, supports the measure.
“The ability of a country to issue compulsory licenses for medicines and
other urgently needed items to respond to a health crisis is not a novel
approach, and is embedded in international trade agreements such as the WTO
Agreement on the Trade-Related Aspects of Intellectual Property Rights.
This is a prudent and reasonable precautionary measure,” said Jim Keon, who
heads the group, in a statement.
As noted previously, the move comes against a backdrop of mounting angst
over the rising cost of medicines, which has prompted a growing number of
countries to consider licenses. But the issue is hardly new. For more than
a decade, licensing has been a controversial flashpoint between
cash-strapped governments and drug makers, which argue that licenses
eviscerate their patent rights.
The new pandemic, however, has ratcheted up this sort of activity. Just
over the past week, lawmakers in Chile and Ecuador passed resolutions
urging their governments to explore licensing. Separately, Israel approved
a license for an HIV pill, prompting the manufacturer to relinquish patent
rights and waive restrictions on generic supplies on a global basis.
Earlier this week the Costa Rican government took the debate a step further
by asking the World Health Organization to create a voluntary pool to
collect patent rights, regulatory test data and other information that
could be shared for developing drugs, vaccines and diagnostics. The goal is
to provide free access or licensing on reasonable and affordable terms, in
every member country.
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