Why Voluntary Licensing is Best for Increasing Access to Medicines

Compulsory licensing has received the most attention as the best way to increase access to medicines in low- and middle-income countries (LMICs). Academic papers, non-governmental organization (NGO) campaigns, conferences, and United Nations (UN)-approved technical symposiums argue that this is the best approach. Certain World Trade Organization (WTO) members have sought to include COVID-19 treatment and diagnosis in intellectual property waivers under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs Waivers) . The agreement revolves around a compulsory license. Brazil recently amended its intellectual property law to make compulsory licensing easier.

Despite its high political profile, compulsory licenses are rarely used (mainly by a few African countries in the mid-2000s to combat the HIV pandemic). Still, IP-respecting treatments available from global procurement agencies are proving to be cheaper. No country has yet recognized the need for compulsory licensing of COVID vaccines.

Meanwhile, quietly, innovative medicines in critical therapeutic areas such as HIV and hepatitis C are reaching patients in low and middle income countries (LMICs) at a rate unprecedented in the last two decades. COVID vaccines and therapeutics are being manufactured at scale, and the latest data show that supply at LMICs continues to outpace demand. No need to override patents or other forms of intellectual property rights (IPR). The lack of access is largely due to the failing health system and increasing COVID fatigue among procuring governments.

This game-changing story is governed by an arbitrary license. Innovator licenses her IP and technology to global partners. Global partners leverage their manufacturing capabilities and local market presence to ensure the supply of quality medicines and vaccines to patients around the world.

A voluntary licensing program for Tenofovir, a patented ARV drug on the World Health Organization (WHO) list of essential medicines, will increase access to 8.7 million patients by 2015, up from 30,000 in 2006. increased and the majority received the generic version.

Elsewhere, Sofosbuvir, a patented hepatitis C drug, has become widely available in LMICs thanks to voluntary licensing agreements with 11 generic companies in India.

These days, voluntary licenses apply to COVID treatments. Among them, remdesivir and nilmatrelvir/ritonavir have the potential to reach more patients with LMICs, thanks to voluntary licenses governed independently and by the United Nations-approved pharmaceutical patent pool. .

Voluntary licensing is a better and more sustainable approach to increasing access to medicines. Here are some reasons.

Wide-ranging technology transfer beyond patents

A compulsory license allows generic competitors to invalidate the patent. But when it comes to making drugs, patents alone are generally not enough. Modern vaccines and medicines are complex and patents alone cannot be easily copied or reverse engineered. Successful licensees require a range of technologies, including but not limited to patents, including know-how, education, skills and other technical assistance.

Many of the manufacturing technologies for vaccines and biologics are embodied as technical know-how specific to each product and cannot be easily transferred. Such information is often known to a small number of people within the innovator organization.

In the case of the COVID vaccine, the originator has entered into voluntary licenses not only for wholesale manufacturing, but also for individual parts of the manufacturing process. Both approaches helped drive rapid manufacturing on a scale far beyond the founder’s capabilities.

Licensing within an agreed IP protection framework is critical to each of these deals given the amount of proprietary and commercially sensitive information shared.

Each partnership involves the transfer of vast amounts of data and know-how, with dozens of innovators’ expert staff devoting their time to guiding and overseeing the safe and accurate transfer of manufacturing knowledge. Such methodical knowledge transfer should only be done in an environment where intellectual property rights are protected to prevent partners (perhaps competitors in other fields) from using the information for their own benefit. can be done.

In contrast, such close cooperation is highly unlikely under compulsory interventions such as compulsory licensing, and would-be manufacturers are encouraged to develop and devise their own manufacturing processes. be forced to. This is a time consuming and expensive task. Voluntary cooperation is always desirable.

quality assurance

Another strength of the voluntary licensing approach is its focus on quality. This is a real problem given the various scandals and quality issues surrounding certain substandard medicines sold in low-income countries.

The Pharmaceutical Patent Pool (MPP), which manages voluntary licensing of products for use in LMICs such as HIV, Hepatitis C and Covid, has strict safeguards in place to ensure drug quality.

To qualify for a license, an MPP licensee must demonstrate that its production facility meets Good Manufacturing Practices. It should also include requirements for pharmacovigilance monitoring and reporting by generic manufacturers. In addition, an adverse event reporting system shall be established prior to commercialization. Licensees must also demonstrate that the infrastructure serving all licensed markets has passed anti-bribery and anti-corruption assessments, export control and trade compliance, and has strict health and safety measures in place. there is.

Most bilateral voluntary licenses also include conditions that require the licensee to adhere to certain quality standards. These licenses also include a commitment by the founders to maintain pharmacovigilance for their licensed products as an additional layer of security for patients.

speed

A Voluntary License (VL) is a faster way to make innovative medicines available in LMIC. Most countries (with the exception of the few exempted poorest countries) have minimum standards for IP protection in line with the WTO TRIPS Agreement. These countries simply cannot invalidate the patent and manufacture. By signing a VL agreement, generic drug manufacturers do not have to wait for patent results, grant patent challenges in advance, or even apply for compulsory licenses. This saves a lot of time and money.

As mentioned above, voluntary licenses also provide a secure platform for sharing sensitive information between licensees and licensees, allowing for faster access. Founders who share their own clinical data with generic drug manufacturers eliminate the need for costly and time-consuming clinical trials. The result is faster production and lower costs.

Flexibility

There are various voluntary licensing models that innovators can choose from, depending on market conditions, needs, and objectives.

One option is a two-way transaction where the originator licenses to one or more generic manufacturers. It has been widely used and successfully used to treat HIV and hepatitis C, and many countries have made significant progress against these diseases. With multiple generic partners licensed, competition further drives down prices.

There is also a centralized “clearing house” model where originators pledge IP to third parties and license them on their behalf according to a pre-agreed set of criteria and standards.

The pharmaceutical patent pool is most notable for negotiating public health-driven licensing agreements with patent-holding pharmaceutical companies, granting royalty-bearing sublicenses to qualified generic manufacturers in developing countries, and granting certain Supply medicines to LMIC.

A 2017 study estimated the actual cumulative savings generated by MPP licensing between 2010 and 2028 at approximately US$2.3 billion. MPP’s operating costs were just $50 million during the same period.

Finally, companies that manufacture complex products such as vaccines and want to maintain control over their marketing and supply chain have the option of licensing individual parts of the manufacturing value chain. As mentioned earlier, this has proven its worth during the COVID pandemic.

Benefits for generics and innovators

Voluntary licensing offers significant benefits to both the licensee generic manufacturer and the originating company. With a license, generic drug manufacturers do not have to challenge the patent or apply for a compulsory license. Both of these are time consuming and costly. In most cases, generic companies would rather cooperate.

Founders have many advantages beyond their desire to provide quality products to previously unserved patients. With Africa’s pharmaceutical market projected to reach US$60 billion by the end of 2023, the size of the opportunity is immense.

Cooperation, not coercion

The success of voluntary licensing in improving access to the most widely applied medicines, such as HIV, hepatitis C and COVID, is essential for intellectual property protection to stimulate future innovation. , shows that it can help meet public health goals.

As the global health debate in Geneva and elsewhere refocuses beyond COVID on how to promote equitable access to all medicines, a voluntary approach is key. Adversarial approaches such as licensing are a time-consuming, risky and ultimately unsustainable way to address global health problems. In contrast, voluntary licensing benefits all stakeholders, especially patients. Cooperation, not coercion, should be the basic principle.

Image Source: Deposit PHotos
Image ID: 143570881
Author: Duy Woy