DESPITE concerns about the potentially restrictive measures, the Pharmaceutical and Healthcare Association of the Philippines (PHAP) has maintained that obtaining a voluntary license is the way to go if other companies seek to produce Covid vaccines. -19.
The industry group said several vaccine candidates have already been approved or have been in advanced clinical trials for less than a year, thanks to technology transfer collaborations between the companies.
“In just a few months, after nearly 300 partnerships around the world, these collaborations have succeeded in increasing production from zero to 2.2 billion doses of the Covid-19 vaccine by the end of May,” PHAP told 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 collaboration with established organizations are models that produce quality and safe vaccines,” he continued.
This is in response to a recent statement by Médecins Sans Frontières (MSF), or Médecins Sans Frontières, which said that intellectual property (IP) holders could put in place certain restrictions preventing voluntary licensing. (Read related story: MSF is not optimistic about Covid jab voluntary licenses, https://businessmirror.com.ph/2021/05/21/msf-not-too-upbeat-on-covid-jab-voluntary-licensing/)
By obtaining a voluntary license, the patent holder grants a generic company permission to produce the patented article subject to general conditions.
MSF legal adviser Yuan Qiong Hu said earlier that the company that owns the intellectual property can dictate who it wants to work with, set the terms and conditions of the license, choose which countries can provide and decide which IPs not. are allowed to produce only at a certain price. label.
With this, MSF has joined the call of more than 100 countries to remove patent protection on doses of Covid-19 in order to stimulate the production of much-needed vaccines.
The United States recently supported the patent waiver, which is seen as prompting other major economies to heed the campaign. (Read the related story: “US Support For Relinquishing Intellectual Property In Vaccines To Influence Other Majors,” https://businessmirror.com.ph/2021/05/11/us-backing-for-vaccine-ip-waiver-to-sway-other-majors/)
Ensure the quality
The pharmaceutical group has however argued that the voluntary licenses guarantee the quality of the doses of Covid-19 to be manufactured.
“The guarantees of voluntary technology transfer include the transfer of know-how, the sharing of expertise and the joint training of qualified workers with the common objective of developing and manufacturing a quality and safe Covid-19 vaccine,” said declared PHAP.
When identifying partners, PHAP said that companies holding intellectual property take into account the ability of the applicant to deliver expected results and quality assurance processes without compromising safety and quality.
“[F]Obtaining the effective intellectual property rights of Covid-19 vaccines may give a company the right to manufacture a vaccine, but without the collaboration enshrined in the voluntary transfer of technology, quality and safety could be compromised. The vaccine development, manufacturing and supply chain process is complex and not as straightforward as “plug and play,” the industry group said.
Terms & Conditions
In voluntary license 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.
Nonetheless, IPOPHL said voluntary licensing agreements should comply with Articles 87 and 88 of the Intellectual Property Code, which relate respectively to prohibited anti-competitive clauses and mandatory clauses.
“Failure to comply with these provisions will result in the non-applicability of the voluntary license agreement to third parties,” IPOPHL CEO Rowel S. Barba told BusinessMirror.
In obtaining a voluntary license for Covid-19 vaccines, Barba cited the following requirements: the licensee’s ability to produce the vaccine, volume to be produced and rate of production, period of license agreements and guarantees from the parties.
“The government and the pharmaceutical companies should seek mutually beneficial terms when negotiating a voluntary license,” Barba said. “It would be counterintuitive for a pharmaceutical company to be very strict in imposing voluntary license conditions, as it will be left behind by other producers / competitors as there are many other companies with which the government can process. “
In addition, the IPOPHL official said governments can issue compulsory or special compulsory licenses “when deployment is slow or hampered by private interests”.
Towards vaccine equity
PHAP stressed that the intellectual property system has enabled the biopharmaceutical industry to respond quickly and responsibly to the current pandemic.
“Foster an environment conducive to innovation by establishing predictable trade policies, enabling responsive regulatory processes, increasing investments in pharmaceutical research, encouraging innovation and forging collaborations with innovative vaccine manufacturers across the world. ‘Global scale will contribute to the short and long term vaccine safety in the country,’ the group stressed.
With this, PHAP said it supports the measures defined by the International Federation of Pharmaceutical Manufacturers and Associations to ensure equity in vaccines.
These commitments focus on the need to step up dose sharing, optimize production, remove trade barriers, support country readiness and further drive innovation on Covid-19, PHAP said.