Pharma Industry Seeks To Bring A Fresh Face To Public Health Policy

The research-based pharmaceutical industry is working to bring a fresh face to the international public health policy arena in Geneva, most recently through a new initiative on technology transfer. Working through the industry’s Geneva-based trade association, the effort to be seen in a more positive light comes after years of doubts about the transparency of its involvement in these issues and could change the tenor of international negotiations.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) this month launched a publication entitled, “Technology Transfer: a Collaborative Approach to Improve Global Health” [pdf].

The report, which envisions a “win-win process,” describes the transfer of technology to low- and middle-income countries as essential for their economic development, and explains the pharmaceutical industry’s contribution to the process.

It profiles more than 50 pharmaceutical tech transfer projects from the past 5 years of IFPMA members across the world, involving manufacturing and entrepreneurial know-how, scientific collaboration and knowledge-sharing, and capacity-building.

IFPMA officially launched the tech transfer report at a 9 March panel event in Geneva attended by officials from governments, international organisations like the World Trade Organization, World Intellectual Property Organization, and a variety of other key stakeholders. The panel, which included an official from the World Health Organization and representatives from Brazil’s Fiocruz and US drug manufacturer Eli Lilly, was moderated by Intellectual Property Watch.

Mario Ottiglio, associate director for public affairs and global health policy at IFPMA, and an author of the report, said it is not intended to be comprehensive, but rather gives a trend and for the first time reveals industry’s insights on the topic.

The report says that “the rewards to companies transferring pharmaceutical technology to emerging countries are often reputational as well as commercial.” But it says that although tech transfer is sometimes philanthropic, “these collaborations are usually also driven by commercial rationales and market conditions, which are heavily influenced by policy and regulatory decisions made by national governments.”

It also ties industry tech transfer activities to an agreed action to promote such activities under the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property Rights. Implementation of the plan, and financing of R&D for neglected diseases, is the subject of an ongoing discussion at the WHO.

The IFPMA publication sets out ideal conditions for encouraging tech transfer, including: a viable and accessible local market; political stability and good economic governance; clear development priorities; effective regulation; availability of skilled workers; adequate capital markets; strong intellectual property rights and effective enforcement; and a good relationship between industry and government making a long-term effort possible.

For all these factors to be in place for the poorest countries, regional collaborative approaches are most useful, it said. So, first steps tend to be taken with larger developing countries that can provide more of the factors.

At an 8 March press briefing, questions were raised about whether the industry’s efforts are truly tech transfer aimed at the best interests of the countries, or were mainly commercial opportunities such as joint ventures. This includes whether strong intellectual property rights enforcement would be in the best interest of countries that have few IP rights of their own.

The research-based industry continues to garner significant profits globally but has seen generics producers cut into market share, and has concerns about the innovation pipeline and potential future blockbuster products. Still, in a departure from past style, rather than showing bitterness about questions of its business model, industry representatives at the press briefing took a more patient tone with reporters’ probing questions, with only a representative from Eli Lilly becoming defensive at times.

IFPMA Communications Director Guy Willis answered a question about possible harm in the European Union-India trade agreement under negotiation of data exclusivity – which blocks generics from using the origin company’s market data until the patent expires, thereby delaying entry of generics. Willis said such exclusivity is essential for a company that patented early in the development process as it may not have many years left in its 20-year patent life. He said India could decide for itself, and that “it’s about India taking its rightful place in the world” as a research-based pharmaceutical producer, and “not just a generics producer.”

Public health advocates have raised alarm that restrictions on the ability of India, the world’s largest generics producer, to produce affordable generics, could have an enormous impact on the lives of many poor people around the world.

WHO “Mapping” Tech Transfer

Speaking on the 9 March IFPMA panel, Zafar Mirza of the WHO Division of Public Health, Innovation and Intellectual Property Rights said the policy focus has been on meaningful and effective tech transfer that benefits local innovation. WHO is mapping tech transfer to see trends in different kinds of flows (such as North-North or North-South), and hopes by the May World Health Assembly to produce a global trends report showing who is doing what in tech transfer.

WHO also is working in the vaccines area to promote vaccines production in developing countries, he said.

Mirza also made several observations about the tech transfer process, noting, for instance, that the use of economic feasibility as the basis for tech transfer is now considered insufficient, and that countries need policy coherence with a national vision. He also raised that: a “one-size-fits-all” framework is not the adequate; differences should be considered between products – such as medicines, vaccines or diagnostics; local production may raise ethical questions such as if a country with its own needs is exporting all of its output; and that a framework is still lacking for promoting local production. The emphasis should shift away from the industrial development basis toward national health policy and public needs, he said.

Another point raised during the panel discussion was that there may cases where medicines would not have become available if there had been IP protection, such as in the case of tuberculosis, where TB patients may have had to wait years to get access. The WHO recently published, along with UNAIDS and the UN Development Programme, a paper explaining the use of flexibilities built into international trade rules on IP at the WTO. These flexibilities are intended in part to help countries ensure IP rights do not prevent them from addressing public health needs.

IFPMA also planned to participate actively in today’s international Stop TB Day.

Feeling Good About Helping Others Feel Good

The research-based industry is in a tough position, operating a high-investment, for-profit business model with a world demanding affordable access to its products. But it seems to be trying to embrace its role in the process, and is speaking of consensus and working together with international organisations and governments.

Under Director General Eduardo Pisani, IFPMA has issued a glossy brochure in UN blue entitled, “Fostering a Positive Dialogue on Behalf of the Research-Based Pharmaceutical Industry.”

“Our objective is to build trust and help to find broadly supported solutions to the huge and complex issues facing society in the arena of human health,” Pisani is quoted saying in the brochure.

The research-based industry – as distinct from the generic pharmaceutical industry which borrows on previously conducted research in order to provide inexpensive versions of existing drugs – is hoping to better explain its business model and the issues that it faces. This means explaining how it develops medicines, the regulations under which it operates, and the roles of other stakeholders.

A key element of the pitch is the concept of partnerships, which is also a buzzword in WHO negotiations to find alternative funding sources for research into neglected diseases – those mainly afflicting poor populations, and for which there is little commercial market. Partnerships can mean public support for engaging private sector expertise in otherwise unprofitable activities.

Antonio de Pádua Barbosa, vice-director for Bio-Manguinhos Production at Fiocruz, a quasi-governmental group in Brazil, described how tech transfer agreements have led to vaccines development while providing royalty returns for the companies.

He said that now Brazil is in a position to demand more than just the technology in the transfer. It remains to be seen whether that will be the case for the poorest countries too.