Population Briefs > June 2006, Vol. 12, No. 2 > Meeting Explores Pricing of Pharmaceutical Products


Population Briefs: Reports on Population Council Research

June 2006, Vol. 12, No. 2

Drug Development
Meeting Explores Pricing of Pharmaceutical Products

For decades, patients, doctors, ethicists, and other observers have debated the economics of the pharmaceutical industry. What is the best way to get medications to the people who need them, regardless of their ability to pay for these drugs? Can prices can be lowered without jeopardizing basic research for new drugs? Are drug company pricing practices monopolistic? What are the legal and ethical obligations related to drugs developed—partially or fully—with public funds?

The Population Council convened a daylong meeting of an eminent group of academics, scientists, representatives from the nonprofit sector, the pharmaceutical industry, foundations, and government donor agencies, as well as practicing lawyers and doctors—all of whom have a connection with pharmaceutical products. The purpose of the Day of Dialogue was to explore ways of getting medicinal products—especially those invented and developed partially or fully using public funding—into the hands of the poor people of the world, wherever they live.

F.M. Scherer—Emeritus Harvard University John F. Kennedy School of Government professor and current lecturer at Princeton’s Woodrow Wilson School—spoke about the economics of pharmaceutical research and development and product pricing. Scherer’s analysis of profits from pharmaceutical sales and investments in research and development (R&D) showed that when profits increase, so does R&D. This suggests that pharmaceutical companies engage in what economists call “virtuous rent-seeking.” However, said Scherer, there is still cause for concern. Most R&D is for diseases prevalent in industrialized countries, not those in developing countries. And, while profits themselves drive R&D, so does the threat that a company will lose profits (via patent expiration, for example).

Arthur Caplan—chair of the University of Pennsylvania’s department of medical ethics—explored the question “Can ethics save pharma?” Caplan acknowledged that U.S. government funding is limited and will remain so for a while. He stated that those who seek innovation in drug availability and pricing will need to look to the pharmaceutical companies. Potential partners of pharmaceutical companies, however, must recognize and find ways to manage the ethical problems of the industry. Moreover, the pharmaceutical industry should rededicate itself to its scientific foundations and commit itself to heeding ethical guidance on how it carries out research, marketing, and sales.

Bayh–Dole Act
One of the key issues that arise in discussions of pharmaceutical pricing is the Bayh–Dole Act, a 1980 law that governs the status of intellectual property resulting from research funded fully or partially by the U.S. government. The law allows universities, businesses, and nonprofit organizations to retain rights to inventions they make or develop with federal funding. In exchange, these organizations are required, among other things, to promote and attempt to commercialize such inventions. Previously, these rights were held by the government. Because organizations did not own the rights to their inventions, they had no incentive to pursue them to commercialization. Government agencies that funded the research often did not pursue the commercialization of the products either. As a result, products based on government- funded research rarely reached the public.

Some observers have argued that the Bayh–Dole Act states that inventions produced with government funding must be made available to the public at a “reasonable price.” However, this contention has been publicly refuted by Senators Birch Bayh and Robert Dole, the co-sponsors of the legislation, and by experts in patent law, including Howard Bremer, an expert on the law who spoke at the meeting.

The final segment of the day featured a videotape of Patricia M. Danzon, professor of health care systems and insurance and risk management at the University of Pennsylvania’s Wharton School. She presented a proposal for differential drug pricing through confidential rebates. Discussion of the video was moderated by Ernst R. Berndt, professor of applied economics at the Massachusetts Institute of Technology’s Sloan School of Management and the National Bureau of Economic Research. In Danzon’s proposed system, manufacturers would sell their products to wholesalers, who would then distribute the drugs at a uniform price worldwide. The manufacturers would negotiate confidential rebates with the final purchasers.

Conclusions
Each of these presentations spurred spirited discussion and debate among the attendees. Participants reached several conclusions during the day’s discourse. Among them:

  1. Big pharmaceutical companies possess chemical libraries that may include compounds that could be developed into useful drugs; ways should be found for nonprofit research organizations to make use of these resources.

  2. Intermittent funding does not enable organizations to pursue drug development; new approaches and mechanisms are needed to ensure consistent funding.

  3. The public funding expended before the licensing of a pharmaceutical product is dwarfed by the amounts spent by drug companies to test, obtain approval for, and market these products.

  4. A major task is to find appropriate ways for donors to subsidize approved pharmaceutical products for those unable to afford them.

  5. License agreements from publicly supported research organizations can include reasonable pricing clauses, tiered royalty rates, and indigent access programs.

  6. Getting new products to the dock at a low price in a developing country does not solve the problem. Product introduction, adequate distribution channels, and infrastructure for delivery are also required. Attending to these issues requires time and money.

Source
Duclayan, Gina. 2006. “Day of Dialogue on Public Sector Pricing of Pharmaceutical Products,” report of a meeting. New York: Population Council. (PDF)

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See Also

  • Foundations: Making contraceptives available,” overview (full text)

  • Making contraceptives widely available,” Population Council 2003 Annual Report (full text)

  • “The Population Council joins forces with Schering to establish the International Contraceptive Access Foundation,” news release (2004) (full text)



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27 July 2006