Big Pharmaceutical Firms Say MDGs Partnerships Are ‘Best-Kept Secret’

While global drug companies say they are on the forefront of increasing access to medicines in developing world for sake of global health, some question true commitment of the industry

NEW YORK – The vast collaboration between the pharmaceutical industry, government and civil society is perhaps “one of the best-kept secrets of our industry,” the head of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) said this week, stressing the need for even more cooperating heading into the post-2015 development agenda at the United Nations.

As governments gathered in New York this week to review global efforts in achieving the UN Millennium Development Goals (MDGs) and plan how to reach – and surpass – those goals beyond 2015, pharmaceutical industry leaders called for continued dialogue and engagement from all stakeholders.

The UN called for the engagement of both business and civil society in order to achieve MDGs, yet provided no clear blueprint as to what role the private sector should play, Eduardo Pisani, director general of IFPMA, told those attending a 24 September reception at Pfizer in New York, just blocks from the United Nations.

Yet since the MDGs launch in 2000, more than 220 partnerships have been formed to address a wide range of diseases, improvements in health system infrastructures training, pharmaceutical research and development, and medicine and vaccine donations. These partnerships, led by pharmaceutical companies, have improved the health of people in low- and middle-income countries, and can serve as a model for how to make the most progress on the health-related MDGs, according to industry officials.

Proven successes in reducing the child and maternal mortality rates, and deaths related to tuberculosis (TB) and malaria, for example, are among the reasons Pisani said he likes to “view the glass half full…. But despite the significant progress that has been made primarily through collective action, we need to do more.”

To maximise global health goals, there needs to be broad engagement to frame the next MDGs.

“There is no single sector … that can drive the systemic changes that are required to address the most complex health challenges we are facing today,” Pisani said. There is a “shared commitment to build a healthier world,” he added.

‘If You Want to Go Far, Go Together’

Aron Cramer, president and CEO of Business Social Responsibility (BSR), said public-private partnerships are “absolutely an essential way” to make progress on MDGs, but added, “sometimes it’s more complex to work within networks.”

Citing an old African proverb, Cramer said: “’If you want to go fast, go alone. If you want to go far, go together.’ I think network-based actions to make progress follow this.”

He added that despite challenges that may arise in group action, sustainable development goals can be achieved.

“Let’s not be stuck in gridlock,” Cramer said. “Let’s just keep going and accelerate and get on our way.”

Mel Spigelman, president and CEO of the TB Alliance, agreed that these partnerships have indeed borne fruit. For instance, the past few years have seen the first new diagnostic brought into the tuberculosis space in well over half a century, he noted, adding that Johnson & Johnson recently won US regulatory approval for its tuberculosis tablet Sirturo, the first drug in 40 years that provides a new way to treat TB.

While the US sits on the “largest portfolio of potential new products” for TB, Spigelman said, “clearly, the glass is half full. However … it’s much, much, much more difficult to fill that second half of the glass than it is that first half.”

“There has to be a true doubling or tripling of effort” of what has been happening over the past 10 to 15 years among these partnerships to really make an impact, he said, adding that there has been a “retrenchment” from big pharmaceutical companies in terms of involvement.

Spigelman’s group pointed to a 2012 report released by the Treatment Action Group on TB research funding that highlights R&D funding in the TB space, specifically, how current levels of investment in this area fall well short of target funding levels set forth by Global Plan to Stop TB 2011-2015 [pdf], issued by the WHO/Stop TB, and funding levels have been largely stagnant in recent years. The report notes that despite the $19.2 million in additional resources, 2011’s TB R&D investment total represents only 32 percent of the annual $2 billion funding target set by the Global Plan to Stop TB.

“Research to accelerate global TB R&D is gravely under-funded,” the report states. “More donors are needed to fill the annual $1.35 billion funding gap and the TB community at large must renew its commitment to achieve zero TB deaths, zero TB infections, and zero suffering from TB.”

Along those lines, David Bryden, TB advocacy officer for RESULTS – an organisation that aims to battle poverty and its root causes, including access to medical care – also questioned how needy patients can have better access to life-saving drugs, and said companies need to better adhere to principles enunciated in the MDGs.

In response, Caroline Roan, vice president of corporate responsibility for Pfizer and president of the Pfizer Foundation, referenced her company’s recent deal with Sequella, a clinical-stage pharmaceutical company commercialising antibiotics to treat life-threatening infectious diseases. Sequella has licensed Pfizer’s exclusive worldwide rights to develop and commercialise sutezolid, an antibiotic in development for TB treatment.

“We think they’re best equipped to get it to patients most quickly. Some people disagree with that decision and we respect that,” Roan said. “The pharmaceutical industry takes very seriously its responsibility to increase access to medicines.”

Giving Up Patent Rights Key to Deploying Medicines

Along with donating medicines to reach certain MDG targets, IFPMA notes in a report released this week that voluntary and royalty-free licenses are also indicative of the industry’s commitment to the global cause. A voluntary licence is an authorisation given by the patent holder to a generic company to make the patented product as if it were a generic, making it cheaper to buy. Also in play are non-assert declarations, where a patent rights holder decides not to enforce certain patents in certain groups, allowing a generic version of that product to be produced. Generics aren’t necessarily prolific in countries where IP rights are rarely sought; they still need economically-viable markets in which to operate, where business costs are reasonable.

Pisani said voluntary licensing activities have existed for many years; the practice has determined a series of collaborative programs between international drug manufacturers and domestic companies – some in South Africa and India, for example – to initiate a sort of technology transfer to get drugs to those who need them.

For example, many people in least developed countries (LDCs) and low-income countries (LICs) have gained access to life-saving antiretrovirals for HIV/AIDS treatment in part because of access initiatives that do not rely on intellectual property rights. Differential pricing and capacity building systems are also put into place. Some examples of companies giving up their patent rights include:

• Roche has halted patent filing and enforcement in LDCs, and won’t enforce existing patents for its antiretrovirals in sub-Saharan Africa, allowing generics to be produced and reach 70 percent of all people living with HIV there.
• Merck granted royalty-free licences of its ARV efavirenz to five South African generic manufacturers.
• Pfizer created the Diflucan Partnership in 2000 to provide treatment for two AIDS-related fungal infections in developing countries; millions of Diflucan treatments have been distributed for free to governments and NGOs in developing countries.

One initiative many say is a prime example of how various stakeholders should be working together is GHIT – the Global Health Innovative Technology Fund.

Launched in April 2013 by the government of Japan, five leading Japanese pharmaceutical companies, and the Bill & Melinda Gates Foundation, the GHIT Fund is a new model for fighting neglected diseases, offering drug companies a commercial model for developing products not likely to provide fast returns on investment. Launched with a more than $100 million in investment capital, GHIT provides grants to collaborations between Japanese and non-Japanese entities for the development of new health technologies, to spur R&D partnerships that can create new drugs, vaccines, diagnostics and other tools for fighting infectious diseases in the developing world.

While drug companies’ – or any companies’ goal, for that matter – is to make a profit, the expertise at those companies is still needed to help those in need in underdeveloped countries and to help unleash company-owned technologies “for the sake of the poor,” said Shiro Konuma, director of the Global Health Policy Division at the Ministry of Foreign Affairs in Japan.

“Technology should benefit the health of all people,” Konuma said.

Spigelman said that within mere weeks of the GHIT Fund launch, his group was already in talks with other groups to increase TB screenings. “This one is real,” he said.

This type of organisation forms “a tremendous underpinning that now can interact with the rest of the world to bring progress as a time when it is most needed,” Spigelman continued.

“I think it is a model that can be emulated by a lot of other countries and a lot of other institutions to really put some meat behind the words.”