Lead Author: Jon Pender
Organization: GlaxoSmithKline
Country: UK

Abstract

While some tensions may remain between international human rights law, trade rules and public health objectives, the last 15 years have seen a number of initiatives pursued by the pharmaceutical industry and other stakeholders which have brought significant improvements in access to medicines. Intellectual property plays a vital role in facilitating innovation and this is covered in a separate submission from GSK. This paper describes some of the new business models that GSK and others have adopted, focusing on research and development (R&D) models for diseases of poverty, when IP is not always a sufficient incentive. 

We believe these approaches are bearing fruit and that the Panel should consider how they could be scaled up and built upon. This approach of building upon successful initiatives is more likely to make more progress more quickly than unpicking existing frameworks and models and trying to create and agree new ones. 

We propose that the Panel: 
1. Acknowledges that the private sector, working in collaboration with other sectors, has an indispensable role to play in developing products for diseases which disproportionally affect the developing world
2. Endorses Product Development Partnership (PDP) approaches in which the costs and risks of R&D are shared, reviews the progress made by PDPs, such as the Medicines for Malaria Venture (MMV), the Malaria Vaccine Initiative (MVI), the TB Alliance and the Drugs for Neglected Diseases initiative (DNDi) and identifies best practices
3. Calls for a wider funding base for these PDPs
4. Focuses on ensuring that the products developed by these PDPs reach the people who need them as quickly as possible
5. Considers whether there is scope to expand the PDP approach to meet other unmet needs
6. Encourages greater use of open innovation approaches for diseases of the developing world including mechanisms such as Open Labs and WIPO Re:Search
7. Supports a menu of incentives which in combination will stimulate more R&D by more companies for diseases of the developing world
8. Recognises and encourages efforts by companies to expand access to existing products
9. Supports the new business models and approaches, such as tiered pricing and partnerships to strengthen health systems, being increasingly adopted by companies
 

Submission

New Models for Innovation and Access for Diseases of the Developing World - Building on what is already working

GSK’s mission is to enable people to Do More, Feel Better and Live Longer. We have an important role and responsibility in improving the health of people around the world. 
Innovative medicines, vaccines and consumer healthcare products contribute enormous benefit and reassurance for individual citizens, and increased economic efficiency and competitiveness for society. The most important thing GSK can do is to continue to discover, develop and supply products that address unmet need and improve quality of life – and to work with others to make these medicines accessible as widely and rapidly as possible to people who benefit from them, wherever they live. 

GSK is playing an important role in addressing the health and sustainability challenges of the developing world. Our efforts include evolving new business models and forging innovative partnerships in wide-ranging areas such as R&D, disease elimination programmes, community partnerships, voluntary licensing and increasing the affordability of our products.1 Our approach has been recognised via our top ranking in every edition of the Access to Medicines Index.2
GSK is evolving its business model based on the twin imperatives of innovation and access. We will invest in R&D to discover and develop medicines and vaccines to meet unmet needs. We will then seek a return on that investment, and measure our commercial success, by providing access to those products for as many people as possible. 

Pricing of medicines must balance the needs of multiple stakeholders. We aim to strike a fair and appropriate balance between the need to reward innovation with the broader cost expectations of payers and other stakeholders. 

Prices should enable optimal use of resources for healthcare systems, recognising the potential for medicines to slow the progression of illness and prevent costlier medical care; improve access to value-adding medicines for patients; and reward added-value to encourage further research and scientific breakthrough. 

GSK is focusing on delivering medicines and healthcare products to the 6.5 billion people across all countries of the world who are becoming increasingly significant consumers of healthcare products.

We seek to price our medicines and vaccines responsibly and sustainably to reflect both the value they deliver - to patients and their families, healthcare systems and wider society – and the customer’s ability to pay, wherever in the world they are. Our tiered pricing approach on vaccines and our commitment to price patented medicines in the world’s Least Developed Countries at 25% or less of European prices are strong examples of this approach. 

When IP may not be a sufficient incentive

The R&D based pharma industry wants to be able to develop medicines to meet unmet medical needs wherever they occur. However, the return on investment on R&D for diseases of the developing world is often too low to justify an adequate allocation of resources.

Product Development Partnerships
To address this dilemma, we are increasingly working in Product Development Partnerships (PDPs), which share the scientific and financial risks and can help to initiate and accelerate R&D. Typically, the model involves companies providing the technology that they have invested in for decades, as well as their development and distribution expertise, to the partnership. Public sector partners help fund the development costs while also helping to ensure that the medicines and vaccines developed get to the people who need them by financing implementation programmes. This has the dual benefit of encouraging R&D and accelerating the products’ uptake in the developing world.

A number of these PDPs such as the Medicines for Malaria Venture (MMV), the Malaria Vaccine Initiative (MVI), the Drugs for Neglected Diseases Initiative (DNDi), and the TB Alliance have transformed the pipeline of R&D projects for diseases of the developing world. Research programmes are overseen by joint steering committees with representatives from all the partners. Under the terms of the agreements, where sales opportunities exist priority must always be given to treatments for neglected tropical diseases in the LDCs, and many contain provisions on affordable pricing, for example “no loss, no profit” models.

The PDP approach is working. A report from Policy Cures published in February 2016 showed that 485 products were in the pipeline for products to fight diseases of the developing world3 the vast majority being developed in partnerships. GSK has worked with many of the major PDPs since their inception. A case study on GSK’s partnership with the MVI to develop the world’s first malaria vaccine is provided in Annex A. These PDPs are reducing the costs of development; making products more affordable by delinking the price charged from the costs of R&D; and getting new products to patients faster.

The data from the independent G-FINDER4 report, which analyses investments in R&D for diseases which disproportionately affect the developing world, has shown that these approaches have fostered increased investments by the industry. In the latest G-FINDER report aggregate industry investment in R&D for diseases of the developing world was US$534m, making the industry second only to US NIH in the list of funders of research in this area.

This collaborative approach adopted by the industry was further illustrated by its response to the Ebola outbreak in West Africa. GSK, MSD and J&J all responded quickly to the crisis, working at an unprecedented rate to accelerate the development of their candidate vaccines. By working closely with partners including the World Health Organization (WHO), making significant investments, and doing normally sequential activities in parallel to speed up vaccine development, the companies were doing in around 10 months what could usually take more like 10 years.

Knowledge Pools and WIPO Re:Search
In 2009, GSK created the Pool for Open Innovation against Neglected Tropical Diseases (POINT). By emphasizing a more accessible approach to intellectual property and know-how, POINT facilitated access to intellectual property and/or technologies for organizations that wanted to conduct research on treatments for these neglected diseases. In addition to including our IP in the pool, stakeholders told us that they would like to be able to access our knowledge, know-how and experience in R&D. The pool evolved therefore into more of a Knowledge Pool.

This led to the creation of WIPO Re:Search in 2011 by the World Intellectual Property Organization (WIPO) in collaboration with BIO Ventures for Global Health (BVGH), and with the active participation of leading pharmaceutical companies and other private and public sector research organizations. Its 101 members represent a wide range of private and public sector research organizations from six continents.

GSK is a member of WIPO Re:Search where member organizations share IP, compounds, expertise, facilities and know-how with qualified researchers working on new solutions for NTDs, malaria and tuberculosis. WIPO Re:Search is bringing innovative medical technologies to the fight against these diseases by brokering new research partnerships and sharing knowledge.

WIPO Re:Search consists of an online, freely accessible database of IP, technology and other knowledge assets, and a Partnership Hub administrated by BVGH, a leading non-profit global health organization. BVGH connects potential users and licensees of WIPO Re:Search, creating research collaborations and ensuring WIPO Re:Search assets are being used productively.

WIPO Re:Search Members include some of the world’s largest pharmaceutical companies, prestigious academic institutions and product development partnerships. The Consortium is a voluntary endeavour of members that endorse the WIPO Re:Search Guiding Principles, which include a commitment to:

  • provide royalty-free licenses for research, development and manufacture anywhere in the world
  • make products available royalty-free to all Least Developed Countries
  • consider in good faith access for all developing countries, taking into account the economic development of the countries and the need to facilitate access to disadvantaged populations.

Open Innovation
More and more companies are pursuing open innovation approaches for diseases of the developing world. For example, GSK’s approach to open innovation includes:

  • Being more open with our IP – As noted above, GSK created the world’s first patent pool for neglected tropical diseases, which led to WIPO Re:Search. In 2013 through ViiV Healthcare, its HIV joint venture with Pfizer and Shionogi, GSK joined the Medicines Patent Pool (MPP) and in 2014, just two months after regulatory approvals, ViiV Healthcare announced licences with the MPP for dolutegravir for both adults and children in countries with the highest HIV burden. For children, generic manufacturers now have a royalty-free voluntary licence to develop paediatric formulations of dolutegravir in 121 countries, where 99% of children with HIV live. The licence also includes paediatric formulations currently in clinical development
  • Being more open with its resources – GSK has established an 'open lab' at its dedicated diseases of the developing world R&D facility in Tres Cantos, giving independent scientists access to its expertise, facilities, knowledge and infrastructure to work on their own projects. In 2014, 26 visiting scientists made use of the Open Lab which has built up a portfolio of over 50 research 26 Feb 16 projects since it was established in 2010. Recognising the growing disease burden form noncommunicable diseases (NCDs) in Africa, GSK has expanded this concept and has committed a £25 million investment to establish the world’s first Africa NCD Open Lab. In this project, GSK scientists will collaborate with researchers across Africa to address the specific variations of NCDs in Africa. GSK and the UK and South African Medical Research Councils have together pledged £5 million to help South African researchers study NCDs as part of the Open Lab initiative. In November 2014, GSK committed a further £4 million to support successful proposals for NCD research from Cameroon, Cote D’Ivoire, Ghana, Kenya, Malawi, Nigeria, The Gambia and Uganda.
  • Being more open with its data and compounds - GSK spent 12 months screening two million molecules in its compound library for activity against the deadliest malaria parasite, P. falciparum, yielding more than 13,500 hits. The results were published in the journal Nature and all the data was posted on a number of freely available scientific websites. GSK has also run similar screens, and made the results public, against TB, African sleeping sickness and Chagas disease.

Potential Incentives
It is important to create the right environment to encourage more companies and institutions to be active in R&D for diseases which disproportionally affect developing countries. There is no single magic bullet to incentivise more R&D for DDW. A number of complementary new mechanisms need to be considered to stimulate more research in this area, including:

  • Transferable extensions of Market Exclusivity/Patent Rights for novel proofs of concept and new, licensed products
  • Increasing funding for currently available developing world product purchases
  • Increased public sector funding for clinical trials and the scale-up of production facilities
  • Tax credits and orphan drug laws for DDW research
  • Streamlined regulatory processes for new vaccines and medicines

Other GSK Programmes to Expand Access
In addition to our efforts in R&D, GSK is pursuing other approaches to ensure access to medicines and to minimise the impact of any policy incoherencies.

Innovative business models and partnerships
GSK continues to seek creative new business models and external partnerships to help improve access to medicines. Some of our longstanding and more recent initiatives include:

  • The creation of a new operating unit dedicated to the LDCs in 2010, to provide a strategic focus on expanding access to medicines for patients living in these countries, including price caps on patented products at 25% or less of European prices. We aim to improve access to healthcare for 20 million underserved people by 2020.
  • A tiered pricing policy for our vaccines dating back over 30 years - typically 70 - 80% of all the vaccines we sell go to developing countries. In 2015 we announced that we would freeze our prices for Gavi graduating countries for 10 years so that they pay the same discounted price for GSK vaccines for a decade from end of GAVI support. 5
  • Our 2014 announcement extending the tiered pricing model to our prescription medicines. We develop pricing strategies based on country-specific circumstances, such as patient affordability, the local healthcare system, and other social and economic factors. In Bangladesh, for example, sales of Cexime have grown by 60% over four years since we reduced the price to help more people access this oral antibiotic.
  • The launch of ViiV Healthcare in 2009: a joint venuture with Pfizer and Shionogi dedicated to the discovery and delivery of new and better treatments for HIV/AIDS patients worldwide, and increased access through licencing.
  • Africa Strategy6 launched in 2014 in which our goal is to make our products accessible and available to 80% of the African population by 2020. This isn’t philanthropy. It’s a new way of doing business. In addition to the NCD Open Lab described above, we are investing up to £100m in local manufacturing and are supporting 25 academic chairs in African Universities in areas such as pharmaceutical and clinical sciences, public health, manufacturing and logistics to help create a workforce with the necessary skills.
  • A partnership with the Brazilian Government’s Oswaldo Cruz Foundation (Fiocruz) since 1985, to manufacture vaccines for public health priorities in Brazil including polio, Haemophilus influenzae type b (Hib), measles, mumps, rubella, rotavirus.
  • A groundbreaking five-year partnership with Save the Children with the aim of combining our resources and expertise to help save the lives of one million children. Our initiatives include developing child friendly medicines; training healthcare workers; and working together to increase access to medicines more broadly. So far we have reached over 3.6 million people including 1.3 million children with life-saving immunisation and treatments since 2013.
  • A 5 year £22m partnership with Comic Relief in which we are teaming up in support of global efforts to strengthen health systems’ capabilities to fight malaria.

Conclusion
Where IP is not a sufficient incentive to stimulate R&D for diseases of poverty, the industry has an impressive track record of pursuing innovative partnerships and collaborative approaches to share the costs and risks of R&D where no commercial return can be expected. These approaches are working and have transformed the landscape of R&D into diseases of the developing world. We believe the Panel should consider how they could be scaled up and built upon. This approach of building upon successful initiatives is more likely to make progress more quickly than unpicking existing frameworks and models and trying to create and agree new ones. There is more that can be done, especially in creating the right environment to build and scale up these approaches. At GSK, we will actively seek new partnerships, new ways of doing things, and new approaches to address the needs of our customers and patients. Ultimately, we will ensure sustainable business performance that generates value for our shareholders while doing what is right for patients and customers.

Bibliography and References

1 http://www.gsk.com/responsibility.html 

2 http://www.accesstomedicineindex.org/ 26 Feb 16

3 http://pipeline.policycures.org/ 4 https://gfinder.policycures.org/ 26 Feb 16

4 https://gfinder.policycures.org

5 http://www.gsk.com/en-gb/media/press-releases/2015/gsk-extends-its-price-freeze-commitment-to-ten-years-for-countries-graduatingfrom-gavi-support/

6 http://www.gsk.com/en-gb/media/press-releases/2014/gsk-announces-new-strategic-investments-in-africa-to-increase-access-tomedicines-build-capacity-and-deliver-sustainable-growth/