Innovative Approaches to Pharmaceutical Innovation: Alternative R&D Mechanisms

by Adriana Lee Benedict

Earlier this year, the World Health Organization’s Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) issued a report calling for, inter alia, increased support for innovative pharmaceutical R&D funding mechanisms.  Although lack of financing has posed a challenge to implementation of alternative approaches to R&D, the increasing pace of pharmaceutical innovation has certainly spurred significant innovation in this realm.  These approaches can be broadly categorized into “push” and “pull” incentive mechanisms.

“Pull” mechanisms–such as advance market commitments, prize funds, and expedited regulatory review—reward R&D outcomes by facilitating translation of innovation to marketable products.  Several “pull” mechanisms have yet to be tested.  For instance, pay-for-performance mechanisms, such as those contemplated by the proposed Health Impact Fund, would use government and donor financing pay for performance in lieu of normal profits gained from market exclusivity.  Other untested ideas include patent buy-outs, transferable IP rights and market exclusivity, reduction of patent length, and “optimal hedging to smooth public health expenditures”.

“Push” mechanisms, on the other hand, fund R&D at earlier stages. Patent pools, for instance, bring patents into a collectively owned and managed pool that can issue voluntary licenses to generic companies for product development. Other “push” mechanisms that have seen some success include targeted disease-specific funding, health innovation networks for the “Global South”, capacity-building and technology transfer initiatives, open-source and crowd-sourced R&D for neglected and rare diseases, and private-public product development partnerships.  “Push” mechanisms that have been proposed but not yet tested include taxes on patents; proportional, tiered or stage-specific partial prizes; and making undisclosed clinical trial data an international public good. Innovative financial proposals that de-link R&D investment from profits include linking donor funding to technology transfer commitments, cost sharing for clinical trials, for-profit investment partnerships, neglected disease and global health tax credits, and additional fees on patent applications (called “Green IP”).

Read More

TOMORROW: Glenn Cohen on Action Speaks! Diamond v. Chakrabarty

Tomorrow, Wednesday, October 3 at 5:30 pm, Bill of Health co-editor I. Glenn Cohen will participate in a live national broadcast on Actionspeaksradio.org regarding Diamond v. Chakrabarty, the 1980 case that first established the right to patent life.

For information on how to listen or attend the recording live in Providence, RI, click here. And for some background from Glenn on the case and current issues, click here and here.

Reproductive Politics

By Michele Goodwin

In recent months, women’s reproduction has been in the spotlight.  A few weeks ago, the Republican Party adopted an anti-abortion platform calling for a constitutional amendment outlawing abortion and making no exception for victims in cases of incest, rape, or to save the woman’s life.  Ironically, some of the very same party leaders responsible for drafting the amendment issued demands for the Missouri Congressman, Todd Akin, to resign or step aside in a hotly contested Senate race after he made controversial claims that “legitimate” rapes rarely result in pregnancies.

As the gender war plays out in high profile ways, we should be aware that abortion politics is not the only area in which women’s reproductive rights are closely scrutinized and under threat of political attack.  Relatively little attention has focused on the pernicious on-the-ground forms of criminal policing targeted at pregnant women across America.

Since the late 1980s, state legislatures have enacted criminal feticide laws that now ensnare women for a broad range of activities, including falling down steps, suffering drug addiction, refusing cesarean sections, or attempting suicide. For example, in 2010 Utah Governor Gary Herbert signed into law the “Criminal Homicide and Abortion Revisions Act,” which specifically applies to miscarriages and other fetal harms that result from “knowing acts” committed by women.  A prior version of the bill drafted by state legislator Carl Wimmer authorized life imprisonment for pregnant women who engage in reckless behavior during pregnancy that could result in miscarriage and stillbirth.  Arkansas, Florida, Minnesota, and some other states define child abuse as intentional or neglectful harm to the fetus.

Read More

To Tell or Not to Tell: Should Researchers Contact Anonymous Donors to Help Them?

By Cansu Canca

A recent New York Times article drew attention to an issue with increasing importance as technology develops. Gene samples collected under conditions of anonymity reveal more and more information that may be of crucial importance for the subjects or their relatives. Researchers feel a moral obligation to disclose these important findings, which may even be life-saving, to the subjects. Yet, the anonymity clause in the consent forms prevents them from doing so.

Whether or not researchers can or must disclose the information in spite of the anonymity clause mainly turns on two issues: the scope of the informed consent and the reach of the obligation for beneficence.

Read More

Intellectual Property in Investment Agreements: More “Teeth” for Foreign Investors’ IP Rights, Less for Access to Medicines

By Adriana Benedict

Last week, Public Citizen published a Health GAP analysis entitled “Leaked TPP Investment Chapter Presents a Grave Threat to Access to Medicines,” in which Professor Brook Baker explains four ways in which access to medicines is compromised by the USTR’s leaked investment chapter proposal for the Trans-Pacific Partnership Agreement.  The problematic provisions he identifies — inclusion of intellectual property (IP) in the definition of “investment”, ambiguous scope of minimum standards of treatment, inadequate exceptions and limitations for public interest measures, and performance requirement limitations preventing development of local and sustainable production—are not new, but have been included either implicitly or explicitly in countless bilateral investment treaties (BITs) (including the U.S. Model BIT) and the investment chapters of free trade agreements (FTAs) (including virtually all US FTAs and the proposed EU-India FTA).  Such inclusion gives more “teeth” to foreign investors’ IP rights, but what of access to medicines?

Read More

The Body Snatchers: Human Recycling in The Global Age

By Michele Goodwin

For all the attention by legal scholars, doctors, and politicians to the global organ shortage—and particularly the crisis in the United States, relatively little is said about tissue demand and that supply industry.  Well known are the horrific stories involving black markets specializing in organs like kidneys and livers.  The troubling stories of Indian women, Pakistani men, and Brazilian boys pillaged for parts and left suffering with grotesque scars, owing debts, and in medical need are chronicled by a growing chorus of scholars (see here, here, and here).  Even those of us who support incentives to encourage organ donation strongly oppose human rights abuses paraded as free markets.  What scholars continually overlook, however, are the surreptitious, global tissue trades that effect more people and have the potential to cause greater harm, such as diseased tissues, bones, and other body parts entering the stream of US commerce and transplantation.

Several years ago, I presaged some of these problems and wrote about these issues; one of the articles can be found here.  More recently, an international consortium of journalist have come on board with an eye-opening special report, revealing black markets in Europe for human tissues and bones.  Their story begins in the Ukraine, where earlier this year security guards discovered body parts and skin stuffed into coolers, and envelopes filled with cash–transported on a “grimy white minibus.”  Authorities stumbled onto this body part heist thinking that a mass-murder had been uncovered. To their surprise, the bus and its contents were headed off to Germany before shipment of the parcels to Korea, the US and other countries.

On its own, tissue transplantation makes as much sense as organ transplantation, because they help to improve patients’ quality of life and in some instances may be vital to saving lives, such as heart valve transplants.  The problem is that the dark-side of this industry operates nefariously.  Sometimes this includes pillaging parts from cadavers dead from communicable diseases such as HIV and hepatitis or acquiring tissues through illegal means, or mislabeling parts—claiming that body parts are from Germany, when in fact they are from developing countries.  Often companies that trade on stock exchanges are linked to the darker side.  For example, investigators discovered that a US business, RTI, located in Florida is linked to the Ukraine discovery.  As Dr. Martin Zizi remarked to reporters, “once a [body part] is in the European Union, it can be shipped to the U.S. with few questions asked…They assume you’ve done the quality check, [but] we are more careful with fruit and vegetables than with body parts.”

Read More

New Product Liability Regime for Stem Cell Products?

By Hyeongsu Park

In May 2012, Health Canada granted market authorization for Prochymal. This decision is the world’s first regulatory approval of a stem cell drug (as well as the first therapy for acute graft-vs-host disease, a serious complication of bone marrow transplantation that kills up to 80% of children affected). Like Prochymal, many stem cell products have exciting therapeutic potential, such as bone regeneration and cartilage formation. And the global stem cell product market is estimated to reach $6.6 billion by 2016. However, side-effects remain unknown, and the regulations for such products are largely non-existent. So what should happen if a patient gets hurt?

Stephen R. Munzer (UCLA School of Law) discusses this question in his latest article in the Boston University Journal of Science and Technology Law, and recommends that qualified strict liability should govern product liability for stem cell products. Read More