In the News

Washington Post Editorial

WITH A NAME like the Affordable Health Choices Act, you'd think the health-care reform bill that passed the Senate Health, Education, Labor and Pensions Committee this month would have made an effort to provide affordable health choices. But instead, the bill includes a provision that would create a 12-year market exclusivity period for brand-name biologic drugs. This would drive costs to consumers above even current levels, making the title little more than a mockery.
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By Liza Porteus Viana
Intellectual Property Watch

As the United States Congress prepares to recess in early August, there’s hope - and dread, depending on which “side” of the debate you’re on - that legislation creating a regulatory pathway for follow-on biologics may be pushed through as part of the broader healthcare reform package.

The biologics debate centres on how to bring “biosimilars”- as close to generic versions as possible - of complex, living, and expensive biologic drugs to market so cheaper versions are available for consumers. These drugs have the potential to treat debilitating diseases like cancer, Multiple Sclerosis and Alzheimer’s. Brand-name drug companies, which are producing the bulk of these products, spend billions of dollars and many research hours producing biologics, and they want to protect their research and product as long as possible before generic companies can try to replicate the drugs in order to gain as much profit as possible.

But generics companies, consumer groups and others say this is another attempt by the big brand-name pharmaceutical companies to monopolise the market and prevent people from being able to access cheaper medicines. According to the Federal Trade Commission, in 2007, Americans spent $286.5 billion for prescription drugs; $40.3 billion of which was for biologics.

“Sadly, the Congress is seriously considering legislation that would undermine the best chance we have to provide a market-based approach to moderate the cost growth in the most rapidly inflating, highest-cost element of the pharmaceutical industry - biotech drug products,” said Kathleen Jager, president of the Generic Pharmaceutical Association (GPhA).
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Sarah Rimmington and Robert Weissman
The Roanoke Times

As Congress considers health care reform, many members are suggesting that reform must be tempered in light of the potential expense of expanding coverage.

Why in the world, then, is that same Congress on the verge of adopting an amendment to the health care legislation that will cost consumers and the government tens of billions of dollars? And will Rep. Rick Boucher, who holds a key position on the relevant House committee, vote to support a giveaway worth tens of billions of dollars to Big Pharma and the biotech industry, or will he support common-sense measures to control drug costs and foster marketplace competition?

Big Pharma is today salivating at the prospect of hijacking the health care reform process to enhance its ability to price-gouge the American public.

As the House Energy and Commerce Committee meets to vote on health care legislation, it is expected to consider an amendment from Reps. Anna Eshoo of California, Joe Barton of Texas and Jay Inslee of Washington state -- supported by Big Pharma and the biotech industry -- to authorize generic competition for biotech drugs. Currently, there is no regulatory process for approval of generic versions of this class of pharmaceuticals, known as "biologics."

Biologics make up roughly half of the most important new medicines. Important biologics include many or most new cancer drugs, drugs for the treatment of severe arthritis and psoriasis, multiple sclerosis and numerous vaccines.

Biologic drugs are the fastest-growing segment of the pharmaceutical market, and they are priced significantly higher on average than brand-name conventional drugs. For example, the top-selling biologic, Enbrel, Pfizer/Amgen's arthritis treatment, costs $15,000 to $20,000 per patient per year. Roche/Genentech's cancer drug Avastin costs approximately $185,000 per year.

These extraordinary prices do not reflect high manufacturing or research and development costs. Shielded from competition, brand-name companies charge so much simply because they can.
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By Sarah Rimmington and Robert Weissman
Special to the San Jose (Silicon Valley) Mercury News

As Congress considers health care reform, many members are suggesting that reform must be tempered in light of the potential expense of expanding coverage.

Why then is that same Congress on the verge of adopting an amendment to the health care legislation that will cost consumers and the government tens of billions of dollars? And will Rep. Jerry McNerney, D-Pleasanton, who holds a key position on the crucial House committee, vote to support a giant giveaway to Big Pharma and the biotech industry? Or will he support common-sense measures to control costs and foster competition?

By GOLDIE BLUMENSTYK
The Chronicle of Higher Education
Washington

Two groups that represent tens of thousands of students involved in medical research are taking the Association of American Universities to task for its “unconscionable” endorsement of a proposed federal law that would guarantee drug companies 12 years of exclusivity to sell certain kinds of drugs and vaccines they develop.

The groups say the association’s position on so-called follow-on biologics, or “biosimilars,” puts the universities’ profit motives ahead of the needs of the public.

The measure will “dramatically restrict access to affordable medicines and likely cost consumers and the federal government billions of dollars,” say the American Medical Student Association and Universities Allied for Essential Medicines, in a letter to the AAU. A third organization, a consumer group called Essential Action, also signed onto the letter.
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The Inter-American Dialogue asked Essential Action and others to respond to a series of questions on Venezuela's recently announced plans to review its patent system for an article that appears in today's copy of its English-language daily bulletin, "Latin America Advisor." The questions are posted below, as are Peter Maybarduk of Essential Action's responses. If you wish to read the entire article, which also includes responses by David Vivas-Eugui of the International Centre for Trade and Sustainable Development, José Luis Di Fabio of the Pan American Health Organization and Adrian Cruz of Cross Keys Capital, you can download the bulletin here: IADVZprinted.pdf

Inter-American Dialogue's Latin America Advisor
FEATURED Q&A
Will Venezuela Move to Modify Pharmaceutical Patents?

Question
Earlier this month, Venezuela's trade minister said the government was carrying out a review of patents, including those on pharmaceutical products, arguing patents elevate the prices of goods and fill the coffers of multinational corporations. Leaders of Venezuela's pharmaceuticals industry say revoking patents and allowing drug makers in Venezuela to produce patented medications could discourage foreign investment in Venezuela and also cause shortages of medicine. Do you agree? Will more medicine reach the neediest people if patents are revoked? How much do protections for intellectual property rights matter in Latin America's health systems?

Answer: Peter Maybarduk, Essential Action Access to Medicines Project

It’s worth clarifying what the Venezuelan government has and has not said. The government announced plans to review patent rules. Improving public access to medicines and generic medicine manufacturing capacity are key priorities of this review. The government has not yet announced a detailed policy, and statements by some government opponents seem to have exaggerated the substance of the announcements. A clarifying source is Venezuela's intellectual property office, SAPI, which has posted notices on the subject: http://www.sapi.gov.ve/.
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IP-Watch
By David Cronin

BRUSSELS - India’s status as a top world supplier of generic medicines could be threatened by a free trade agreement its government is negotiating with the European Union, a new study has concluded. Separately, the World Customs Organization has abandoned its intellectual property rights enforcement group, replacing it with a non-policymaking information committee.

A draft of the proposed agreement, available here [1], put forward by EU officials recommends that it should incorporate a wide range of intellectual property issues. According to Carlos Correa, a professor in the University of Buenos Aires, at least two of the provisions in the draft could hamper access to affordable medicines for developing countries.

In an analysis of the accord, Correa concluded that it could require India to forbid the manufacture of generic versions of patented drugs for up to five years after the patents in question expire. While the official rationale behind the EU’s proposal is that such an extension would offer compensation for the time it has taken the patent-holder to obtain marketing authorisation for a particular drug, Correa argued that it would have adverse consequences for the poor as it would delay the reduction of drug prices.

Another provision would offer protection to test data submitted for the approval of branded medicines for a certain length of time (the precise duration has not yet been specified by EU officials). In effect, this would bar makers of generic drugs from using that data.

Until now India has been opposed to introducing such a form of data exclusivity, Correa noted, adding that the EU recommendations go beyond the scope of the key international IP law: the World Trade Organisation’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement.

The question of access to medicines was one of the main issues debated at a public meeting held in Brussels on 10 June, organised by several consumer and health action groups.

Peter Maybarduk from the Washington-based organisation Essential Action said that a number of studies have estimated that the costs of medicines can fall by between 40 percent and 80 percent once generic versions of patented drugs become available. Despite the health benefits associated with this reduction, he complained that a number of governments from industrialised countries have been pursuing an “enforcement agenda” which places greater emphasis on the profits of corporations than on public needs.
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Scrip News
By Francesca Bruce

The Colombian government will not be declaring Abbott's antiretroviral Kaletra (lopinavir plus ritonavir) to be of public interest, leaving the patent on the product intact until 2016. Civil society has accused the government of putting politics first.

The decision comes soon after the government set a price ceiling for Kaletra (scripnews.com, May 13th, 2009). NGOs had been pushing for the government to declare the drug to be of public interest and to issue a compulsory licence, claiming that Kaletra's high price barred access to the drug (scripnews.com, July 29th, 2009). However, the government rejected this, largely on the grounds that all patients who required Kaletra were covered by some sort of health insurance and did not have to pay for the medicine. This was also one of the main arguments put forward by Abbott, according to the government in its justification for the decision.
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By Peter Maybarduk
The Wall Street Journal
Letter to the Editor

Roger Bate correctly identifies the danger to patients posed by substandard medicines ("China's Bad Medicine," op-ed, May 5). But his article tends to confuse public health and patent and trademark concepts.

One reason this matters is poor drug quality is a much bigger public health problem than just fakes.

Another is that brand-name drug companies, unfortunately, are exploiting public fear of fakes to reinforce patent monopolies -- in some cases demanding public officials treat generic competitor drugs as "counterfeits" that may infringe patents and should be subject to the same aggressive seize-and-destroy tactics applied to fake medicines. Dutch authorities' recent seizure of legitimate generics (which Merck requested be destroyed), in transit to treat HIV/AIDS in South America, is an example.

Whether a drug infringes a patent is an entirely separate inquiry from whether a drug is substandard or otherwise unsafe. Public policy should be careful to maintain this distinction, as overzealous government efforts to anticipate patent infringement can limit access to affordable and lifesaving generic medicines. They can also leave taxpayers footing the bill to protect drug firms' monopolies.

Peter Maybarduk
Essential Action Access to Medicines Project
Washington, D.C.
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By Kiernan A. Murphy and Kaitlin Mara
Intellectual Property Watch

Key players in the biotechnology industry are leading an effort to obtain global approval processes for generic biological medicines, which experts say could provide cheaper access to costly but widely prescribed and promising treatments.

These highly complex medicines, many of which have recently or will soon come off patent, are difficult to produce and reproduce and highly expensive to purchase.

This raises questions about how patients can access these cutting-edge technologies, and whether the creation of generic versions – called biosimilars, biogenerics, or follow-on biologics — is feasible. Key issues with biosimilar creation include the question of who owns the right to use data from clinical trials, and whether it is possible to make versions of such complex products similar enough that they can be substituted for the brand-name originals.

The term biologics generally refers to protein-based medicines, as opposed to chemical based medicines, and their production involves genetic manipulation and large-scale cultures of living cells rather than chemical synthesis. This means that “biologics are inherently much more difficult to copy and to replicate than small-molecule products,” said Hans Sauer of the Biotechnology Industry Organization (BIO). Slight modifications to the production process may induce biologics to behave differently.

The Center for Biologics Evaluation and Research, part of the US Food and Drug Administration, notes that biologics are often “at the forefront of biomedical research” and “may offer the most effective means” to treat medical conditions “for which no other treatments are available.” They also cost on average twenty-two times more per daily dose than traditional chemical medications, according to a 2008 paper by Boston University economics professor Laurence Kotlikoff [pdf].

What constitutes appropriate regulation for these new technologies is still being considered, and multilateral discussion is still in its fledgling stages. Outcomes arising from select areas of the world - the recent European guidelines or the result of the current US debate - are likely to shape international policy on these issues.

Thus, debates over regulation of and access to biologics are set to become increasingly important. In the United States, this has been primarily an “industry versus industry fight, brand name versus generic,” said Sarah Rimmington of think-tank Essential Action.

However, Sauer said lines between these stakeholders are blurring, with a “pretty diverse field of industrial participants” — from classic generics companies to emerging biotechnology companies to the traditional innovator companies — interested in biosimilars.
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