Merck has a corporate and ethical responsibility — and the ability — to help accelerate access to our medicines and vaccines in least developed countries where access is most lacking. Middle income countries and emerging markets such as China, Brazil, South Africa and India, offer opportunities to expand our business and provide our medicines and vaccines to new patients in a fair and responsible manner. We are developing new ways and models of doing business in these markets to meet the unique challenges they present.
The challenges surrounding access to medicines are multi-faceted and complex, but we recognize that as a pharmaceutical company we have a unique role to play and a responsibility to offer assistance when social, political and economic conditions make it impossible for patients to receive our life-saving therapies. Merck is working to leverage our expertise to help remove the barriers that stand between patients and the therapies they need. We do this through a combination of business and philanthropic policies, programs and initiatives described below, and we measure our progress on most of these programs and initiatives annually.
In addition, Merck has a long history of both in-house research and external research collaborations that enable innovation in neglected tropical diseases that are most prevalent in developing countries. We continue to seek ways in which we can contribute expertise and resources to these disease areas.
Global Product Registration and World Health Organization Pre-Qualification
Merck is committed to registering our medicines and vaccines worldwide — including in all countries in which it conducts clinical trials — in an expedient and transparent fashion. Toward this end, we have set a goal to reduce the historic gap of 10 to 12 years between product introduction in developed and developing countries with each new product and vaccine we introduce. For example, through a first-of-its-kind donation and partnership program, launched in 2006, Merck introduced ROTATEQ® (rotavirus vaccine, live, oral pentavalent) in Nicaragua, marking the first time there was access to a vaccine in a developing country in the same year it was first licensed in a developed country. We also are developing benchmarks and metrics that can chart our progress toward accelerating access to new vaccines, particularly ROTATEQ and GARDASIL® [human papillomavirus quadrivalent (types 6, 11, 16, 18) vaccine, recombinant]. It is important to recognize, however, that regulatory approval depends on local regulatory processes.
To increase the transparency of the Company's product registration status, we are disclosing registration for ROTATEQ, GARDASIL, and our four ARVs and we plan to update this information every six months:
ROTATEQ (
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GARDASIL (PDF*)
ATRIPLA (PDF*)
CRIXIVAN (PDF*)
ISENTRESS (PDF*)
STOCRIN (PDF*)
Merck announced that it had received WHO prequalification for GARDASIL in May 2009, for MMRII in December 2008 and for ROTATEQ in October 2008. STOCRIN® (efavirenz)2, CRIXIVAN® (indinavir sulfate) and ATRIPLA® (efavirenz 600 mg/emtricitabine 200 mg/tenfovir disoproxil fumarate 300 mg)3, our treatments for HIV and AIDS, have received WHO prequalification. Merck is committed to work with WHO for the pre-qualification of ISENTRESS® (raltegravir). As it is required by the pre-qualification process, Merck is awaiting the inclusion of ISENTRESS in WHO's Expression of Interest and will be ready to submit the necessary documents. WHO prequalification verifies that medicines and vaccines meet the requirements of quality, safety and efficacy of UN Agencies, including UNICEF and the Pan American Health Organization, and is an important step toward providing global access.
Differential Pricing
Merck has a worldwide tiered-pricing strategy for our HIV medicines and offers no-profit pricing in the developing world for two of our vaccines – ROTATEQ and GARDASIL. The strategy considers a number of important factors including burdens of illness, levels of economic development, affordability and sustainability. Merck is committed to making medicines and vaccines available at dramatically lower prices (including selected products that are offered at a price at which Merck does not profit) in the poorest countries of the world, at significantly reduced prices in middle income countries, and at competitive prices in high income countries. We believe that our pricing approach is sustainable, and has contributed to improving access to our medicines and vaccines, while also taking into account Merck's need to continue to invest in research, development and production and to provide an attractive return to our shareholders.
Click here for more information on our HIV pricing policy
Click here for more information on our vaccine pricing policy
In recent years, new funding and collaboration mechanisms to help accelerate access to medicines and vaccines in the developing world have become available, including the Global Fund for HIV/AIDS, TB and Malaria, the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), UNITAID, the Clinton HIV/AIDS Initiative and the GAVI Alliance. We support these mechanisms, as well as Advance Market Commitments, priority review vouchers, the recent International Financing Facility for Immunization (IFFIM) bond floating introduced by the U.K. government and other innovative mechanisms that hold great promise in expanding access to much-needed vaccines in the developing world. Merck has and continues to provide input to these programs not only regarding ways in which industry can provide skills, resources and products relevant to the program goals, but also has made specific commitments through these collaborations.
Intellectual Property Protection and Licensing
Ninety-five percent of medicines and vaccines described as essential by the World Health Organization are not patented in the developing world. Despite this, very few people in developing world countries have access to the medicines they need. A complex array of factors create practical barriers to care.3 We believe that intellectual property protection, including that afforded through patent systems, is instrumental in providing incentives for innovative pharmaceutical companies to perform the risky and costly research and development required to bring new life-saving medicines to market. Businesses will not invest in new research efforts if they do not believe that such research will generate revenue that can be used to recover the costs of such investments and to support further research and development. Effective patent systems are a key driver of research because they provide some assurance that, if a new drug is successful, it will generate some revenue for the patent holder. We also believe that incentives to innovation are ultimately the key driver for competitiveness at the country level, generating economic development and social prosperity. Actions to reduce incentives to innovate will adversely affect research and development of vital new drugs, which is an unacceptable prospect at a time when resistance to medicines, including, for example, antibiotics and antiretrovirals to treat HIV and AIDS, is on the rise and new products are critically needed.
For this reason we support and advocate for effective intellectual property protection in developing and developed country markets, as outlined in the TRIPS agreement. Our policy and our practices recognize the public health flexibilities contained in the TRIPS agreement. However, we also believe that these flexibilities were designed to provide exceptions to the rules. If they become the rule, then incentives for innovation will be reduced in ways that could affect all countries, leading to a decline in biomedical innovation. It is also important to note that Merck believes that once a patent has expired on any of our products, that patented invention should be in the public domain, available for use by others. To read Merck's policy on compulsory licensing click here.(PDF*)
Merck supports the role of quality generic medicines in health care systems around the world. While we will vigorously defend our intellectual property rights, it is not our policy to do so in a manner that would undermine access to medicines in countries where such medicines have been manufactured and may be sold free of intellectual property rights.
On December 4, 2008, a shipment of generic Losartan, the active pharmaceutical ingredient found in COZAAR, a Merck antihypertension drug, was going through The Netherlands on its way to Brazil, and was seized on charges of patent infringement. The Dutch Authorities informed Merck, and Merck sent notifications of the Dutch patent violation to the carrier, the manufacturer and the importer from Brazil. In this case, Merck acted within its legal rights to enforce a valid patent in the Netherlands. As a policy matter, however, we should have taken greater consideration of the fact that the shipment was bound for a country in which Merck does not have patent rights. We have ensured that our policies and internal procedures have been clarified on this point.
Licensing
Merck considers licenses for our medicines to further increase their availability, but to grant such licenses we must first ensure that the licensee’s product is of sufficiently high quality and that they will be able to assure uninterrupted supply. To date, Merck has granted royalty-free licenses of our anti-retroviral efavirenz to five South African generic manufacturers, of which four are currently on the market. For more information, please click here.
External Manufacturing Approach
Merck is committed to seeking additional ways to reduce the cost of our medicines and vaccines and increase access for people living in the world's poorest countries. This includes working with external manufacturers and suppliers to achieve incremental efficiencies and to reduce or waive the royalty on vaccine doses sold in the developing world. In 2008, CSL Limited, a licensing partner, agreed to waive Merck’s royalties for sales of GARDASIL in the developing world to help expand access to GARDASIL. CSL's decision to waive the royalties will result in lower prices and is an example of how industry partners can work together to develop sustainable solutions for vaccine access.
Product Donations
Merck does not believe that donating medicines and vaccines is a sustainable solution to the global challenge of improving access to medicines. However, we recognize that millions of patients are currently in need of medicines and cannot wait for solutions. In particular, Merck considers donations to be an important mechanism for expanding access to medicines and vaccines where appropriate, and to be particularly relevant in emergency situations and as part of a disease elimination program.
Merck played an important role in the development of the WHO's Guidelines for Drug Donations through our involvement in the Partnership for Quality Medical Donations (PQMD). Merck conforms to the Guidelines. We have also worked with the World Economic Forum to develop new industry guidelines for donations in disaster situations.
Merck has donated it medicines and vaccines since 1958 through the Merck Medical Outreach Program (MMOP) to a selected group of qualified, U.S.-based, private voluntary organizations for use in the developing world and in support of disaster relief and emergency situations worldwide. A significant component of the MMOP is the Merck MECTIZAN® Donation Program, the largest ongoing medical donation program and public/private partnership in history.
The content on this page was last modified on September 15, 2009.
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1Efavirenz is marketed by Bristol-Myers Squibb as Sustiva in the United States, Canada and certain European countries, and by Merck in the rest of the world as STOCRIN.
2ATRIPLA is marketed by Bristol-Myers Squibb and Gilead in the United States, Canada and Europe. Merck and Gilead are working to register and distribute ATRIPLA in 106 developing countries around the world.
3Attaran A. How Do Patents And Economic Policies Affect Access To Essential Medicines In Developing Countries? Health Affairs 2004;23(3):155-166.
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