We recognize that we have a business and ethical imperative to help ensure our products are accessible to patients worldwide. Working to improve access to medicines and vaccines is the right thing to do ethically, and it is a major element of our corporate mission. This focus is necessary to sustain our business in the longer term, and to attract and motivate employees that Merck wants to retain— those committed to making a positive difference to society. 

1. Discovering and developing breakthrough medicines and vaccines that address major burdens of illness globally.   Merck is committed to a research agenda, that reflects not only the global burden of disease but also the need for new treatments for complex and important diseases such as AIDS. In addition to our own research efforts, we have entered into product development partnerships with external researchers and scientific organizations to help accelerate the search for new treatments and prevention options. We are also including pediatric clinical trials in all of the Company's drug and vaccine development strategies worldwide that are relevant for pediatric use. 

2. Developing long-term business strategies and models tailored to the individual needs of least developed countries, middle income or emerging markets and the developed world, which help our products reach the patients who can benefit from them wherever they may live, while also supporting the growth of our business. We also engage in philanthropic activities to support access to medicines and vaccines.

3. Promoting and participating in partnerships with governments, multilateral organizations, community-based organizations, other corporations and non-governmental organizations to help build health care capacity, expand delivery systems and address specific health and development challenges, particularly in the developing world.

Through our multi-pronged strategy, we are improving access to medicines and vaccines by examining our research priorities and developing new ways of thinking about the affordability of our medicines, by reaching for aggressive registration targets and more flexible patent approaches, by developing novel immunization programs and, where appropriate, by providing product donations.

Our strategy is integrated into our decision-making and priority-setting processes across our business:

Key Considerations for Our Business Strategies

In developing business strategies and models that achieve improvements in access, we consider several issues: breadth of registration and World Health Organization prequalification, differential pricing, the returns on intellectual property protection, and major programs and philanthropic approaches.

• Registration: Merck is committed to registering our medicines and vaccines in developing and least developed countries in parallel to developed country registration to the extent permitted by local regulations. A major goal is to reduce the historic time lapse in product introduction between developed and developing countries. In May 2009, GARDASIL^® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant] was the first cervical cancer vaccine awarded WHO pre-qualification. In October 2008, Merck announced that it had received WHO prequalification for ROTATEQ^® (Rotavirus Vaccine, Live, Oral, Pentavalent) and in December 2008, Merck received WHO prequalification for MMR-II^® (Measles, Mumps, Rubella Virus Vaccine Live). STOCRIN^® (efavirenz)², CRIXIVAN^® (indinavir sulfate) and ATRIPLA^® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)³, our treatments for HIV and AIDS, have also 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 is required by UN agencies that often distribute products throughout developing countries, and is necessary in the absence of reliable national medicines safety authorities to certify that products meet required quality, safety and efficacy standards. As such, prequalification is an important step toward fostering global access.

To increase the transparency of the Company's product registration status, we are disclosing registration for ROTATEQ, GARDASIL and our four antiretrovirals (ARVs) and updating this information every six months. Click below for details:

ROTATEQ (PDF*)
GARDASIL (PDF*)
ATRIPLA (PDF*)
CRIXIVAN (PDF*)
ISENTRESS (PDF*)
STOCRIN (PDF*)

• Pricing: Through our worldwide tiered pricing strategy, Merck is committed to making our HIV medicines and vaccines more affordable to more people by applying a differential pricing policy corresponding to countries' level of development and burden of disease. In the least developed countries of the world, Merck sells our ARVs as well as two of our vaccines,  GARDASIL^® and ROTATEQ^®,  at prices at which we do not profit. In middle income countries, Merck provides our ARVs and vaccines at significantly reduced prices, taking into account factors such as relative level of economic development, relative burden of disease, government commitment to treating its population, and the value that Merck ARVs and vaccines have in the local marketplace. In high income countries, we price our products at competitive prices, taking into account the value they provide. We believe that our pricing approach 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. We continuously seek other ways to make our medicines and vaccines more affordable, such as by partnering with external manufacturers and suppliers to achieve incremental efficiencies, and through the issuance of licenses, as we have done already with our antiretrovirals in South Africa.
  
  
• Patents: Ninety five percent of medicines and vaccines described as essential by the WHO are not patented in the developing world. Despite this, very few people in those countries have access to the medicines they need. A complex array of factors create practical barriers to care. Respecting patents and protecting intellectual property are critical to incent research-based pharmaceutical companies to invest in the research and development for new medicines and vaccines. We acknowledge the potential need for the use of the flexibilities accorded in the Doha declaration associated with the TRIPS agreement in the case of true public health emergencies. To read Merck's policy on compulsory licensing click here.(PDF*)
  
  
• Immunization programs: Merck is committed to pursuing programs to demonstrate the feasibility of large-scale immunization and the positive impacts of vaccine introduction in developing countries. For more information, please click here.
  
  
• Product donations: Merck does not believe that donating medicines and vaccines is a sustainable long-term solution to the global challenge of access to medicines. However, we recognize that millions of patients need medicines now and cannot wait for better solutions to make them widely available. For that reason, Merck remains committed to donating our products through the Merck Medical Outreach Program, as we have done for more than 50 years, and through the U.S.-based Patient Assistance Programs. Merck is committed to following the WHO's Guidelines for Drug Donations and to disclosing the U.S. wholesale value of drugs donations. For more information, please click here. Merck also donates our products to researchers for responsible clinical initiatives that will help improve the knowledge base about our products and global health in general, and guide our access strategy. For example, Merck is donating ROTATEQ, its vaccine for the prevention of rotavirus, to PATH for use in clinical trials in Asia and Africa designed to understand the efficacy and safety of the vaccine in developing world environments.

Public/Private Partnerships to Help Build Health Care Capacity, Expand Delivery Systems and Address Health and Development Challenges

Despite Merck's efforts to develop and implement effective philanthropic and business strategies to help remove barriers to access, challenges remain due to the complex and multi-faceted nature of the problem. Improving access requires more than simply making our medicines and vaccines available at fair and affordable prices.

We believe that truly to address – and, ultimately, solve – the issues of access in developing and middle-income markets, the international community must pool its resources and expertise to strengthen health care infrastructure, ensure adequate financing for health, and help to build local health care capacity through training and support. Even in developed countries, challenges remain to reach groups of people that are underserved. But pharmaceutical companies alone cannot solve these public health problems. Sustainable solutions will come from comprehensive approaches that draw on the expertise of all stakeholders.

For this reason, a key element of Merck's access strategy is promoting and participating in public/private partnerships (PPPs) with local communities, governments, nongovernmental organizations (NGOs), multilateral organizations, and other corporations to address specific health and development challenges beyond those over which Merck has direct control.

Merck has three decades of experience in developing PPPs in various areas. In 1987, with many partners, we launched the first large-scale, comprehensive global health initiative of its kind, the Merck MECTIZAN Donation Program (MDP) to provide the drug MECTIZAN^® to treat onchocerciasis, or river blindness, in countries where the disease is endemic. Today, the MDP is recognized as one of the world’s most successful global health care collaborations, and one that continues to have a significant positive impact on tens of millions of people.

Merck has applied our experience with the MDP to programs and partnerships around the world that are helping to prevent and treat HIV and AIDS, other chronic conditions and vaccine-preventable illnesses. While many include financial or in-kind support, Merck also seeks to leverage our expertise and the skills of our employees to contribute in additional meaningful ways.

We work closely with our partners on the ground to formulate specific goals and metrics for the partnerships in which we are involved and we track these over time. For example, the African Comprehensive HIV/AIDS Partnerships (ACHAP) sets targets that are reviewed annually by the ACHAP Board, which includes two Merck representatives. We also have rigorous governance and oversight mechanisms in place for all of our programs and partnerships globally. And we require all of our grantees to submit regular (usually annual) reports outlining how the Merck funds or medicines were used and what was accomplished. For some of our larger initiatives, including the MDP and ACHAP, we have commissioned third-party evaluations of the effectiveness of the programs.

Merck is also actively engaged in research collaborations, including several that involve Merck vaccines. Here too, Merck believes that learning and advancement in both scientific development and access strategies will come from initiatives that involve multiple players, each bringing their unique expertise to the table. For more information on research collaborations in which Merck is involved, click here.

The content on this page was last modified on September 15, 2009.

Merck & Co., Inc., Whitehouse Station, NJ, USA, and Schering-Plough Corporation, Kenilworth, NJ, USA, are now one company. We have combined our global operations under the name Merck & Co., Inc. We are working to update our corporate responsibility Web site to reflect our new, combined, global organization.

---

¹ The Advance Market Commitments are a new approach to public health funding designed to stimulate the development and manufacture of vaccines for developing countries. (Source: GAVI Alliance, Report on Annual Progress ( PDF*) 2007, page 49).

² Efavirenz 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.

³ ATRIPLA 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.