Medicines Patent Pool’s view on the role of licenses for antibiotics – World Intellectual Property Day

2019-04-25

As the world is recognising the World Intellectual Property Day on April 26, we consider how the current system uses Intellectual Property and licenses in the case of antibiotics. Deciphering the role of intellectual property is a critical element in constructing a workable end-to-end model for sustainable access to novel antibiotics. In this interview with Esteban Burrone, the head of policy for the Medicines Patent Pool, we examine the particular role that the Medicines Patent Pool and licensing could play in such an end-to-end model.

There is a critical need to secure sustainable access to antibiotics, both in terms of appropriate use of existing antibiotics and in developing new antibiotics and introducing these in a responsible manner with affordable access to those in need. The current system has not proven to be sufficient for stimulating innovation and securing sustainable access to antibiotics.

There would be a need to rebuild the whole system for innovation and sustainable access to antibiotics, and taking an end-to-end approach throughout the entire lifecycle of an antibiotic. As part of this, a new financing model for Research & Development of antibiotics is needed which delinks the cost of Research & Development from the sales volumes and prices. Governments have a responsibility to ensure a system that is public health needs driven that ensures maximal return on public investment, to achieve affordable access while limiting inappropriate use. While the current system is not working, different options within existing mechanisms could be explored, for example in the case of pooled licenses.

The Medicines Patent Pool (MPP) is a public health licensing agency that negotiates voluntary licensing agreements with drug companies to introduce generic versions of new medicines in low- and middle-income countries. The following interview with Esteban Burrone, head of policy for the Medicines Patent Pool, explores in greater detail some of the dimensions of the role of the MPP, voluntary licensing and intellectual property.

What is the Medicines Patent Pool?

– The Medicines Patent Pool is a public health organization that works to accelerate access to new treatments in low- and middle-income countries (LMICs). We do this by negotiating licenses with the patent holders, which are often pharmaceutical companies, and then providing sub-licenses to generic manufacturers. As a result, more affordable generic versions become available in LMICs that are in the licenses much sooner. Also, treatment programs are able to select the best treatment for people based on clinical needs, rather than cost. At times, licenses have facilitated the development of new formulations that were particularly needed in LMICs, such as new pediatric formulations or new fixed dose combinations that combine multiple medicines into a single pill.

What has been the engagement of the Medicines Patent Pool on antimicrobial resistance?

– Until now, our involvement in the field of antimicrobial resistance has been mainly in relation to our work in the field of HIV, hepatitis C and tuberculosis. For example, we have several licenses on second-line HIV medicines, which are used when people develop resistance to first-line medicines. We also have licenses on new medicines that have a high barrier to resistance and are therefore considered important to delaying the development of resistance to first-line medicines.

– More recently, we have begun to explore a possible role for the MPP in relation to new antibiotics more generally. Recently, seven new antibiotics were submitted for inclusion in the WHO Model List of Essential Medicines, all of which have patents pending or granted in several countries. The MPP will be assessing whether licensing could contribute to making these medicines, or others in the pipeline, available to those who need them in LMICs.

What role does intellectual property play in ensuring the development of new antibiotics?

– As for all pharmaceuticals, intellectual property protection is an integral part of the business model of pharmaceutical companies when working on the development of new medicines.  The exclusivity provided by the intellectual property system seeks to provide an incentive for pharmaceutical companies, and investors, to invest in the development of new treatments.   However, it should be noted that in relation to antibiotics, as for other diseases where commercial returns are either low or uncertain, other incentives are likely required to ensure that the pipeline delivers the kinds of treatments that are needed. As for tuberculosis, the current patent system market exclusivity via patents has not been sufficient to incentivize significant investments in the development of new antibiotics.

What role can or should intellectual property play with respect to stewardship and access (sustainable access)?  What risks are there with the linking of intellectual property with stewardship?

– This is something we are looking at very closely.  On the one hand, licensing can be an effective mechanism for facilitating access in LMICs, as we have seen in HIV and hepatitis C. On the other, there is a need to ensure that some of the new antibiotics, such as those that the WHO may categorize as Reserve antibiotics, are only used as last resort in order to ensure that resistance does not develop. Balancing access and stewardship is key for antibiotics and there are many discussions ongoing among stakeholders to understand different approaches to getting that balance right. Licensing could play an important role, but in the context of a wider set of initiatives and mechanisms needed to ensure access and stewardship.

The Medicines Patent Pool has been primarily focused on negotiating license agreements for medicines to prevent or treat HIV, TB and Hepatitis C. What will be different if and when the MPP decides to negotiate licensing agreements for new or existing antibiotics?

– The model may need to be adapted significantly in the field of new antibiotics partly because of the need to ensure that there is no excessive use that could lead to resistance to new antibiotics, and partly because the market for certain new antibiotics is likely to be significantly smaller.

– In HIV, the MPP provided multiple licenses to multiple manufacturers to compete in the market and bring the price down to affordable levels. That was possible because the market was large and there were significant economies of scale. For new antibiotics, particularly those in the reserve category, the market would likely be very small. The appetite of generic manufacturers to take a license, therefore, may also be small, particularly if there are strict conditions on how and to whom the product should be sold to ensure good stewardship. Thus, additional incentives may be required for such manufacturers to develop the new products and stay on the market. Our licenses might also need to include provisions that ensure supply security, an important issue in the antibiotic space.

More generally, there seems to be a need for stakeholders to come together and agree on what is considered responsible behavior from antibiotics manufacturers. Such behavior could then be required under the licenses thus contributing to promoting access and good stewardship practices.

Many of the new companies developing novel antibiotics are small pharmaceutical and biotech companies, whereas many medicines to treat HIV and TB are developed by large pharmaceutical companies.  What do you anticipate will be different if and when the Medicines Patent Pool negotiates with smaller companies for the in-licensing of antibiotics?

– Several things will be different. One of them is that many of the companies involved in developing the new antibiotics do not have a presence in low- and middle-income countries and often do not have plans on how to make their products available there. Data from recent antibiotics that have entered the market has shown that they are generally being registered in a very small number of high-income countries. This means that unless mechanisms are found to make them available in LMICs, people who may need them in such countries would likely not have access. This is different from situations in which new medicines for HIV or hepatitis C were initially available in LMICs but only accessible to a few that can afford them.

Do you think there is a need to limit the number of generics companies that negotiate license agreements and market new antibiotics?  If so, what are the criteria the MPP should use to select companies?

– We do not know exactly how this would work, as we are currently exploring our role in consultation with a wide range of stakeholders.  We understand that the market itself will likely be small, and therefore the number of manufacturers, would likely need to be smaller to ensure the market remains sustainable. This may however vary between products, and in general, it is a good idea to have some competition in the market.

– In terms of criteria, that too will have to be worked out. I can imagine that among the criteria would likely be the ability to meet quality assurance requirements and a commitment to make the product available in the licensed territory and to comply with any stewardship requirements that are considered appropriate for the product in question.

What is your biggest concern as the MPP looks to enter into this new space?

– At the moment, my biggest concern is the sustainability of the antibiotic market. We are seeing companies that developed some of the recent antibiotics having multiple challenges to remain in the market. This challenge is there as much for the original developers as well as for the generic manufacturers. We are also seeing shortages for certain important old antibiotics.

– Secondly, we would like to make sure that, if the MPP takes licenses, we do so in a manner that supports broader public health goals.  If we are to establish stewardship conditions in the licenses, we should try and make sure that they reflect some level of consensus on what is expected from manufacturers. What is responsible marketing, distribution and supply of a new antibiotic? And if the global community thinks access in LMICs is important, which we think it is, there need to be strategies and funding to make sure that happens.