Submission From: MERCK
Prepared by: Sarbani Chakraborty and Sebastian Gagnon-Messier
Country: Germany
Abstract
This contribution from Merck to the UN High Level Panel on Access to Medicines highlights the importance of intellectual property (IP) protection for stimulating innovation for global public health benefit. The topic of IP and access to medicines is not new – in fact, its discussion at the global health policy level has led to multiple innovative partnerships that have contributed significantly to progressing the health MDGs. There are many barriers to access to medicines requiring a holistic and partnership based approach to bring innovations to patients globally. Merck is committed to promoting access to medicines in the context of the 2030 Sustainable Development Goals. Finding innovative health solutions for communicable and non-communicable diseases and bringing them to scale through partnerships is a priority for Merck. We view intellectual property (IP) protection as a catalyst for continued innovation and improving medicines access at the global level. We believe that to bring these innovations to the global population on a sustainable basis, multi-stakeholders partnerships with governments, private sector and civil society are critical. We commend the United Nations’ recognition of the importance of partnerships as stated in SDG Goal 17 (a successful and sustainable development agenda requires partnerships). By leveraging our core competencies and experience across the health value chain, and fostering multi-sectoral partnerships, we deliver scalable and transformative access programs.
Submission
Section 1: Merck perspective on access to medicines and intellectual property
Merck is grateful for the opportunity to submit comments to the UN High-Level Panel on Access to Medicines. We share the Panel’s commitment to and interest in exploring the delicate and essential balance between the rights of inventors, international human rights law, trade rules and public health.
This balance is an essential element that is the foundation of our Intellectual Property (IP) system. Indeed, this balance provided the underlying rationale for members of the World Trade Organization (WTO) when they adopted the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs). The text of TRIPs makes this clear: “The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.”
The important balance between rights and obligations is reflected by the strict conditions specified for patent applicants and rights holders. First, a patent application requires sufficient information so as to enable any “person skilled in the technological area to which the invention pertains … to make and use the [invention].” This stands in stark contrast to other forms of IP, such as trade secrets, which can allow companies to avoid disclosing such information.
Critically, this disclosure serves an important societal purpose, which is in and of itself a valuable public good. Because the information has been made available, a patent draws on the existing body of scientific knowledge. At the same time, it adds to it so that others may use and benefit from it in their own research. Furthermore, granting innovators protection for their intellectual property makes it more likely that they will collaborate with others, including through the transfer of technology. This collaboration plays a critical role in the fostering of scientific research.
In addition, a patent is limited in two critical ways. Geographically, it is only granted for the country in which it has been filed. Lastly, it is limited in time: patent rights are originally only ever granted for 20 years. It is worth highlighting that the 20-year limit begins when an application is filed, not when a product is marketed.
Filings are therefore required in the earliest days of discovery, given that a patent is only granted for discoveries that are new. Once granted the long journey through clinical development begins. This includes smaller Phase I trials with a small number of volunteers, to Phase III trials which can include thousands of patients. The development program for Merck’s Multiple Sclerosis treatment (Rebif) included over 10,000 patients. Even at the end of a successful development program, the preparation of a submission for marketing authorization is itself a time-consuming and expensive requirement. As a result, from the earliest days in the lab to drug approval and launch, companies face an average of 8 to 12 years of efforts, with no guarantee of being able to launch a drug. This leaves the effective term of patent protection at no more or less than half of the often-quoted 20-year term. Critically, the time needed to secure approval for a new drug has significantly increased in the last decades. This has been driven by multiple factors: authorities may require additional data due to safety concerns, or to “to gather additional information about a product's safety, efficacy, or optimal use.”
Yet even a marketing authorization is not sufficient to ensure that a treatment reaches those who need it. The first company to launch a product, and only the first, must undertake extensive education and information efforts so that doctors are aware of the availability and best use of a new treatment. The inventor company, having completed the full range of clinical trials, is also able to provide comprehensive and accurate information to healthcare professionals and patients. The innovator company is also in the unique position to be the first legally required to fulfill pharmacovigilance requirements. Given the need to closely monitor the safety profile of a new medicine once it is used outside of controlled clinical trials, this too is a vital role filled by innovators.
The steps described above are a necessity in the journey to bring new medicines to market. They are also required even when the possibility of relying on IP rights is limited or non-existent in a given country. Several studies have underscored the role and unique ability of innovative companies to ensure that new medicines are launched and made available. In a 2014 paper reviewing the launch of new drugs in 60 countries from 2000 to 2013, Kyle and Qian found that “patents have important consequences for access to new drugs: in the absence of a patent, launch is unlikely.
Even post-launch and off-patent, generic medicines may not be available at all, or only available at prices beyond the reach of many. Restricting or diluting patent rights cannot be simply assumed to increase access to new drugs. The case of India, home to the largest and most competitive domestic generic drugs industry, underlines this challenge. Writing on access to essential (off-patent) medicines, Maiti et al. write: “The availability of medicines in India is still a big issue. It has been estimated by different sources that 50–80% of the Indian population are not able to access all the medicines they need. Despite having lower prices of medicines in India as compared to the international prices, the availability and affordability is poor.
Patents are not an obstacle to access for any Least-Developed Country (LDC). LDCs have been granted successive waivers to exclude pharmaceutical patents from their WTO commitments. The last one, granted in the fall of 2015, exempts LDCs from enforcing pharmaceutical patents until 2033. As detailed in the Merck Charter on Access to Health in Developing Countries, Merck does not file or enforce patents in 96 countries, a group that includes, in addition to the 34 WTO LDC members, 43 low-middle income countries and 13 Middle-Income countries.
In considering policy solutions to improve access, we call on the Panel to consider solutions that do not undermine innovation and the balance needed in any system. As noted above, IP—in and of itself—has not been an obstacle to access in LDCs. Moreover, the scope of unmet medical needs makes it imperative that R&D into new treatments continues. Yet innovation can only happen if pull mechanisms are in place to incentivize continued research towards new medicines. The IP system has enabled the continued ability of the R&D-based pharmaceutical industry to deliver new and improved treatments for patients worldwide. In 2015 alone, the European Medicines Agency issued marketing authorizations for 39 new active substances, 18 of those for orphan medicines. In addition, it approved 54 new therapeutic indications for already approved medicines. The fruits of these efforts were made possible by the existence of our functioning, well-regulated and balanced IP system.
2. What is Merck doing to address access concerns?
Merck engages in multiple partnerships to drive innovation, and bring these innovations to patients. Below are examples of these partnerships through which Merck is committed to make significant contributions:
A. R&D Innovations to address Communicable Diseases
Schistosomiasis is the world’s foremost neglected tropical disease. This devastating disease causes suffering and debilitation to more than 249 million people and poses a threat to over 700 million people primarily in the world’s most impoverished communities. It is second only to malaria in terms of economic impact. Since 2007, Merck has partnered with the World Health Organization (WHO) to fight schistosomiasis in Africa. Merck has donated more than 340 million Praziquantel tablets, to treat 74 million patients – mainly primary school-age children. In 2014, Merck founded the Global Schistosomiasis Alliance in cooperation with the Bill & Melinda Gates Foundation,the Children’s Investment Fund Foundation, and the Liverpool School of Tropical Medicine.
A key goal of the Alliance is to increase awareness and understanding of what it will take to eliminate schistosomias. The Alliance is, for example, promoting Mass Drug Administration (MDA). Evidence shows that when large scale MDA programmes are implemented in combination with adequate hygiene and sanitation, access to safe water, vector control, and education programmes to inform communities about the disease and how to prevent it, it is possible to eliminate Schistosomiasis. Merck is also signatory to the January 2012 London Declaration on Neglected Tropical Diseases (NTDs). The London Declaration is a public-private effort to eradicate, eliminate and intensify control of 10 of the 17 NTDs (includes schistosomiasis) in order to contribute to the WHO 2020 NTD targets.
Beacuse of tablet size and taste it is hard to adminsiter praziquantel for schistosomias to children under 6. Therefore, an innovation was needed – a new child-appropriate formula. As part of the Pediatric Praziquantel Consortium, Astellas Pharma, Merck and Farmanguinhos, Brazil have been working together to build a solid basis for a new and innovative pediatric formulation.
WIPO Re: Search
WIPO Re:Search is a Consortium sponsored by the World Intellectual Property Organization (WIPO) in collaboration with BIO Ventures for Global Health (BVGH). The Consortium aims to accelerate the discovery and development of medicines, vaccines, and diagnostics to create new solutions for people affected by neglected tropical diseases (NTDs), malaria, and tuberculosis by making intellectual property and knowledge available to the global health research community. These diseases affect more than one billion people across the globe. Merck joined WIPO Re:Search in 2015. In 2015, Merck finalized its first collaboration with the University of Buea in Cameroon, which aims to repurpose compounds from our library to develop a treatment for onchocerciasis, also known as river blindness. Through this collaboration, we are helping to build research capacity, knowledge and expertise in developing countries.
External Translational Innovation Platform (eTIP) for Global Health
Continued research and development innovation is key to improving the lives of millions of children living in low and middle-income countries. "One Merck for Children" is a cross-divisional research and development program under the umbrella of Merck's Global Health Innovation Platform. This external Translational Innovation Platform (eTIP) is working on schistosomiasis, related helminthic diseases, malaria and other major communicable diseases. The aim is to discover and develop sustainable ways to fight these diseases and help underserved populations gain access to better health care. The work is being conducted together with international and local research institutions, and with partners such as the World Health Organization (WHO), the Bill & Melinda Gates Foundation, Medicines for Malaria Ventures as well as governments.
Merck has established a discovery program with external organizations and entered into a partnership with the non-profit Medicines for Malaria Venture (MMV) in 2013. The Merck-MMV collaboration aims at further developing proprietary Merck lead compounds as long-acting anti-malarials, which represent a major gap in the worldwide anti-malarial portfolio. This private-NGO partnership allows resource sharing and uses relevant networks to speed up development. In 2015, Merck announced a research agreement with the University of Cape Town (UCT) South Africa to co-develop a new R&D platform aimed at identifying new lead programs for potential treatments against malaria, with the potential to expand it to other tropical diseases.
B. R&D Innovations and Technology Transfers for Non-communicable diseases:
The non-communicable disease burden is growing every day in low and middle-income countries and the WHO estimates that three-quarters of NCD deaths are occurring in these countries. Moreover, among cancers, colorectal cancer has the fourth highest disease burden globally.
Product Development Partnerships: Merck supports the use of Product Development Partnerships (PDPs) and technology transfers as mechanisms to increase access and improve the health of patients in low- and middle-income countries. On September 9, 2015, Merck signed a Technology Transfer and Supply Agreement (TTSA) for multiple-sclerosis medicines with Bio-Manguinhos/Fiocruz/MoH (Pharmaceutical laboratory that belongs to the Brazilian Ministry of Health) and Bionovis (Domestic private pharmaceutical laboratory). The TTSA establishes a period of seven (seven) years for the Technology Transfer. Immediately after the signature, Merck started the TT procedures and it is expected that during 2016 Bio-Manguinhos will get the Marketing Authorization from ANVISA for betainterferon-1a.
Merck has additional six PDPs granted by the MoH for biological products that are currently under development and these negotiations involves Bionovis and other two public laboratories.
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Access to Innovative Cancer Treatments: Genetic testing to provide targeted treatment is an innovation in cancer care. Merck has developed a program of genetic testing (RAS) to increase detection of colorectal cancer among the population. Merck covers the cost of testing to expand patients’ access to innovative medicines. The Merck screening program allows healthcare professionals to better diagnose the disease in the population-at-risk, and helps them make the right treatment decision for patients. For example. Merck is partnering with the Mexican public insurance scheme (Seguro Popular) to implement a “patient reference program” in order to ease the logistics around access to colorectal cancer treatments.
Innovations to bring quality medicines to patients
Merck Global Pharma Health Fund: Counterfeit medicines cause serious harm to patients, including unnecessary deaths and in the case of antibiotics, can promote antibiotic resistance. Counterfeit medicines are particularly endemic in low and middle- income countries where millions of poor families pay out-of-pocket for medicines. The Global Pharma Health Fund (GPHF) is a charitable organization initiated and funded exclusively by donations from Merck. In 2007, the GPHF took over the work of the former German Pharma Health Fund (1985). The GPHF-Minilab is a mobile mini-laboratory for rapid drug quality verification and counterfeit medicines detection protecting the health of millions of people anywhere in developing countries. It is designed for use in developing countries that lack facilities for effective medicine testing. To date, more than 700 Minilabs have been supplied to health facilities in 85 countries mostly in Africa and Asia. Since 2012, over 50 Minilabs have been donated to thirteen Ministries of Health or National Regulatory Authorities. Data generated by the program have prompted global drug alerts generated by WHO.
The success of the GPHF lies in the ability to form partnerships with governments, non-governmental organizations and faith based organizations. GPHF recently formalized a partnership with the Ghana-based Center for Pharmaceutical Advancement and Training (CePAT) to build local and regional capacity in pharmaceutical quality assurance throughout sub-Saharan Africa.
Capacity Advancement Program for Non-Communicable Diseases (Diabetes) in Africa and Asia
Even when medicines are available, due to lack of awareness and cultural beliefs, people worldwide do not obtain appropriate treatment in a timely manner. Globally, half of the people with diabetes are undiagnosed, and 85% of those undiagnosed are living in low- and middle- income countries. The highest prevalence of people with undiagnosed diabetes is found in Sub-Saharan Africa (78% of people with diabetes are unaware of their status). The Merck Capacity Advancement Program (CAP) addresses this gap by collaborating with Universities and civil society to train HCPs in diabetes diagnosis and increasing public awareness of the disease.
Adddressing the Special Needs of Women and Non-Communicable Diseases: Healthy Women, Healthy Economies
Non-communicable diseases (NCDs) NCDs are the leading cause of death of women worldwide. Moreover, women face many barriers to reproductive health throughout their life cycle. Poor health is one factor that significantly disadvantages women from entering and remaining in the workforce. To address women’s health and economic empowerment, along with key Asia Pacific Economic Cooperation (APEC) countries, Merck launched the Healthy Women, Healthy Economies Initiative in 2015. It includes the development of the Healthy Women, Healthy Economies Policy Toolkit to support APEC government officials, policymakers, civil society and the private sector seeking to improve female economic participation through better health.
Under the rubric of Healthy Women, Healthy Economies, Merck has launched partnerships with governments and NGOs to address thyroid disorders – a major disease among women. More than 200 million people globally suffer from thyroid disorder. Thyroid disorders are seven times more likely to occur among women as compared to men. More than 50 percent of thyroid disorders are underdiagnosed or misdiagnosed, and diagnosis rates in low and middle income countries are particularly small. To advance public awarness of thyroids and enable primary health care providers to diagnose thyroid disease, Merck is partnering with Governments and disease societies in China, India, Indonesia and Philiipines to scale up thyroid diagnosis and treatment. To date 13 million patients have been reached in the Philippines and more than a 1000 hospitals in 100 Chineese cities have implemented thyroid education and awareness programs.
3. Specific proposals
Each of the above mentioned programs or models includes innovative health solutions that are being scaled up in partnership with Governments, other private sector and civil society organizations. These programs have demonstrated success and offer promise if scaled up or replicated in other relevant settings. Innovations in multistakeholder partnerships are key to scaling up global health and we encourage adaptation of such multistakeholder approaches to other countries and contexts to address a full range of global health problems.
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