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PHAP prefers voluntary licensing on vaxx

In this March 18, 2021, file photo, Pharmacist Mia Yu fills a syringe with the Moderna COVID-19 vaccine at a pop up site at Commonpoint Queens The Hub in partnership with the UJA- Federation of New York. Vaccines lessen the risk of severe illness or death from COVID-19, but scientists are still studying how well they prevent the spread of the virus. (AP Photo/Mary Altaffer)

DESPITE concerns about potentially restrictive measures, the Pharmaceutical and Healthcare Association of the Philippines (PHAP) maintained that securing voluntary licensing is the way to go if other companies seek to produce Covid-19 vaccines.

The industry group said that several vaccine candidates have been approved or are in advanced clinical trials already in less than a year,  through technology transfer collaborations among companies.

“In just a few months following close to 300 partnerships globally, these collaborations have been successful in increasing production from zero to 2.2 billion Covid-19 vaccine doses by the end of May,” PHAP told the BusinessMirror. It is estimated that 11 billion doses will be produced this year, the group added.

“At the moment, unprecedented voluntary licensing and technology transfer agreements, bilateral agreements, and working with established organizations are models that are producing quality and safe vaccines,” it continued.

This is a response to a recent statement by Médecins Sans Frontières (MSF), or Doctors Without Borders, who said that intellectual-property (IP) holders could put in place some restrictions preventing the grant of voluntary license. (Read related story: MSF not to upbeat on Covid jab voluntary licensing, https://businessmirror.com.ph/2021/05/21/msf-not-too-upbeat-on-covid-jab-voluntary-licensing/)

In securing a voluntary license, the patent holder grants a generic company permission to produce the patented article subject to terms and conditions.

MSF Legal Advisor Yuan Qiong Hu earlier said that the IP-holding company can dictate who they want to work with, set the terms and conditions for the licensing, choose which countries can supply and decide which IPs are only allowed for production at a certain price tag.

With this, MSF has joined the call of over 100 countries to scrap the patent protection on Covid-19 doses to boost the production of the much-needed vaccines.

The United States recently threw its support behind the patent waiver, which is seen to influence other major economies to heed the campaign. (Read related story: ‘US backing for vaccine IP waiver to sway other majors,’ https://businessmirror.com.ph/2021/05/11/us-backing-for-vaccine-ip-waiver-to-sway-other-majors/)

Ensuring quality

The pharmaceutical group, however, argued that voluntary licensing ensures the quality of the Covid-19 doses to be manufactured.

“The safeguards of voluntary technology transfer include know-how transfer, sharing of expertise, and joint training of skilled workers with the shared objective of developing and manufacturing quality and safe Covid-19 vaccine,” PHAP said.

In identifying partners, PHAP said IP-holding firms consider the capacity of the applicant to deliver the expected output and quality assurance processes without compromising safety and quality.

“[F]orcefully obtaining the intellectual property for Covid-19 vaccines may give a company the right to manufacture a vaccine, but without the collaboration enshrined in voluntary technology transfer, quality and safety could be compromised. The development, manufacturing and supply chain process for vaccines is complex and not as simple as ‘plug and play,’” the industry group explained.

Requirements

In voluntary licensing agreements—which are consensual in nature—the terms of conditions are negotiated by the licensor and the licensee, the Intellectual Property Office of the Philippines (IPOPHL) explained.

Still, IPOPHL said voluntary licensing agreements should adhere to Sections 87 and 88 of the IP code, which are about the prohibited anti-competitive clauses and mandatory clauses, respectively.

“The failure to comply with these provisions shall result in the non-enforceability of the Voluntary Licensing Agreement against third persons,” IPOPHL Director General Rowel S. Barba told the BusinessMirror.

In securing voluntary licensing for Covid-19 vaccines, Barba cited the following requirements: capacity of the licensee to produce the vaccine, volume to be produced and rate of production, period of licensing agreements and warranties of the parties.

“Government and pharma companies must strive for mutually beneficial terms when negotiating for a voluntary license,” Barba said. “It would be counterintuitive for a pharma company to be very strict in imposing voluntary licensing conditions because it will be left behind by the other producers/competitors given there are many other companies government can deal with.”

In addition, the IPOPHL official said governments can issue compulsory or special compulsory licenses “when the rollout is slow or being hampered by private interests.”

Towards vaccine equity

PHAP underscored that the IP system has allowed the biopharmaceutical industry to respond rapidly and responsibly to the current pandemic.

“Fostering an environment conducive to innovation by establishing predictable business policies, enabling responsive regulatory processes, increasing investments for pharmaceutical research, incentivizing innovation, and forging collaborations with innovative vaccine manufacturers globally will help in immediate and long-term vaccine security in the country,” the group pointed out.

With this, PHAP said it supports the measures set by the International Federation of Pharmaceutical Manufacturers and Association in ensuring vaccine equity.

These commitments center on the need to step up dose sharing, optimize production, eliminate trade barriers, support country readiness, and drive further innovation on Covid-19, PHAP said.

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