Pharma Shares COVID-19 Voluntary Licensing Lessons Amid Contestation About Best Path to Access Pandemic Products Medical Innovation 15/06/2023 • Megha Kaveri Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Business leaders and experts from pharmaceutical companies across the world shared their experiences in voluntary licensing during the COVID-19 pandemic. One of the most intense debates in the pandemic accord negotiations is over how to fast-track the development and equitable rollout of vaccines and medicines, with pharmaceutical companies insisting that any infringement on intellectual property (IP) rights will stifle innovation and that voluntary arrangements are the way forward. A recent event to showcase voluntary licensing arrangements during the COVID-19 pandemic was organised by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). It brought a range of pharma companies and their licensees, including MSD and licensee Dr Reddy’s Laboratories, Gilead and Ferozsons Laboratories, Pfizer and Biovac, and Johnson & Johnson and its licensee, Aspen Pharmacare. The panellists expanded on how they voluntarily collaborated with each other and with governments across the world despite lockdowns and supply chain breakages – in an evident rebuttal to their critics who have cast IP rights as a key barrier to more equitable medicines access, saying that IP sharing must be mandatory, not voluntary, in future crises. Expedited innovation – in difficult conditions Since the beginning of the COVID pandemic, a total of 59 vaccines and 44 therapeutics have been approved, said Rasmus Hansen, CEO and founder of the global health analytics firm Airfinity. In addition, 177 collaborations were created to manufacture and commercialise COVID-19 treatments, including 93 voluntary licensing agreements for COVID-19 treatments. Of the 93 voluntary licensing agreements, 84 are currently active, including 80 in developing countries. Manufacturing agreements for therapeutics and vaccines were signed in parallel during the COVID-19 pandemic. (Source: Airfinity) “What we are finding here is pretty much all of the manufacturing announcements involved some kind of collaboration,” Hansen remarked. “I remember we looked at the numbers week on week, and were really astonished to see the output coming from the manufacturers at that point.” Voluntary licensing facilitated swift action The COVID-19 pandemic laid the existing inequity in access to vaccines and therapeutics threadbare. While high-income countries were able to enter into advance purchase agreements with big pharma companies long before the vaccines were ready, low and middle-income countries were forced to navigate arrangements for the local production of new vaccines and medicines that had been developed by the large pharma innovators. South Africa’s Aspen Pharmacare collaborated with Johnson & Johnson to manufacture its COVID-19 vaccine under the name “Aspenovax”, for instance, while Biovac partnered with Pfizer to manufacture mRNA vaccines. “The J&J vaccine was the one that was demonstrating the best prospects for Africa, given Africa’s idiosyncrasies, geographic supply chain and otherwise. We got into discussions with J&J and we were able to move very swiftly to concluding an agreement,” explained Stavros Nicolaou, Aspen’s group senior executive for strategic trade. Aspen was attractive to established companies, said Nicolaou, because of its “strong track record and also a blueprint in the form of voluntary licensing and technology transfers that existed already” as well as two decades of experience. The technology transfer was completed five and a half months after the agreement was signed in December 2021, which was “not an easy task given the severe lockdowns” at that stage. “It’s not like J&J colleagues could jump on a plane and, and travel down south and inspect facilities and do audits,” Nicolaou pointed out, adding that Aspen staff worked 24/7 doing on-camera audits “to give certainty and assurance around quality, safety and efficacy of our manufacturing”. Political complications However, due to a lack of demand for COVID-19 vaccines as the pandemic evolved and the company getting caught in the middle of a political crossfire between Africa and Europe that delayed production, Aspen Pharmacare did not sell a single vial of the vaccine, as reported previously by Health Policy Watch. The political storm revolved around millions of J&J vaccines being produced in Aspen that were due for export to Europe at a time when only 7% of South Africans were vaccinated. South Africa’s President Cyril Ramaphosa intervened, appealing to the Europe Commission head Ursula von der Leyen to prevent this and by September, European countries had agreed to return the J&J vaccines produced by Aspen for distribution in Africa. “There was a standoff between Europe and the African Union in terms of where these vaccines would finally land,” Nicolaou explained at a previous webinar organised by Brown University. “And it took quite significant negotiating and eventually, an agreement was settled between the EU and Africa for some of these vaccines, initially 60% and eventually 90%, to be retained on the African continent.” Therapeutics partnerships Later in the pandemic, as therapeutics also came online, Indian firm Dr Reddy’s Laboratories entered into a licensing agreement with the US-based MSD for the production of the antiviral drug molnupiravir, in January 2022. A Pakistani company, Ferozsons Laboratories Limited, also partnered with the US-based Gilead Sciences to manufacture Remdesivir. Both agreements were signed as voluntary licenses and as part of a long-term collaboration between these companies. Vignesh Shivnath, director of business development alliance management at Dr Reddy’s Laboratories. Despite bitter criticism that developing country markets still got access to such drugs much later and in far more limited quantities, the voluntary partnerships helped to build the capacity of firms in the global south to produce new forms of treatment, panelists said. For instance, early engagement and a bilateral partnership with MSD helped Dr Reddy’s Laboratories mobilise the materials needed to manufacture molnupiravir swiftly, said Vignesh Shivnath, the company’s director of business development alliance management. Dr Reddy’s Laboratories was one of eight generic manufacturers chosen by MSD for establishing bilateral manufacturing agreements. “The direct agreements with Gilead helped us to ramp up technology transfers, quality control and manufacturing roll-out at breakneck speed,” said Osman Khalid Waheed, CEO of Ferozsons Laboratories Limited, about his company’s partnership for the production of remdesivir in Pakistan. Osman Khalid Waheed, CEO of Ferozsons Laboratories Limited (left) and Hemal Shah, Director for Public Policy at Gilead. “I think it was 6 May 2020, when Gilead first reached out to us, and within a week, we had an agreement. Within 12 weeks of that, we were able to start rolling out the product, and sharing information on production and quality control with our partners around the world,” said Waheed. Under the looming shadow of the pandemic accord Referring to the latest draft text of the pandemic accord, Thomas Cueni, IFPMA Director-General, said that he is concerned that, should IP protections for innovative drugs and vaccines be weakened, there is a risk that more “unlicensed, substandard, low quality and counterfeit” drugs and vaccines might be produced in the next pandemic. The risk that new drugs and vaccines might enjoy weakened IP protections could also stymie investments in health tools that would be needed to confront the next pandemic, he warned. “In terms of the pandemic treaty, I have to admit, I’m deeply concerned that the zero-draft is potentially undermining innovation,” Cueni said. Member states of the World Health Organization (WHO) are currently in the process of negotiating a binding instrument for pandemic preparedness, prevention and response. At the Intergovernmental Negotiating Body’s (INB) sessions this week in Geneva, African countries criticised the latest draft text, produced by a guiding body of six member states called the “Bureau”. They called it “weak”, especially in matters concerning equity. “The African member states recognise the hard position that the bureau finds itself in trying to keep everyone at the negotiating table… “However, it is unfortunate that, in that process, the core of what this instrument is supposed to address, namely equity, has been presented in a weakened or reduced format, especially in those articles that would result in a meaningful realization of equity,” Ethiopia said, on behalf of the 47 countries in Africa. Additional reporting by Kerry Cullinan. 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