Medical Students Assail Research Universities Over Drug-Exclusivity Bill

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 proposed law is now the focus of intense lobbying here, pro and con, from an array of interest groups, including AARP (which opposes a long period of exclusivity for fear that it will raise medical costs) and the Biotechnology Industry Organization (which favors it, saying it will encourage companies to invest in innovation).

The student groups and other opponents of the measure fear that if the proposed law is added to health-care-reform legislation now moving through the U.S. House of Representatives, it will be hard to stop. The House may take up the bill as early as this week. The 12-years-of-exclusivity measure is already included in the Senate’s version of a health-care-reform bill.

The AAU, which represents more than 60 top research universities, says it supports the measure because commercial drug companies need assurance that it will be worth it to them to invest in the high-risk business of making the new biologic drugs from inventions coming out of university laboratories. The exclusivity provision is designed to let them recover the costs of their investments before copycat versions of the drugs are allowed onto the market.

Dealing With Copycats

“This is a very new field with dramatic possibilities, and we would like to see it work,” said John C. Vaughn, executive vice president of the association. In practice, he added, the exclusivity provided for in the proposed law would not be all that different from what is currently allowed for “small molecule” drugs.

Biologics, which are based on proteins, are more complex in structure and more difficult to make than small-molecule drugs.

Biologics are also harder to protect with patents because drug developers, by tweaking just a few protein strains, can design around the patented idea and create an imitation drug that does the same thing as the original.

Under current federal rules for generic small-molecule drugs, which are literally copies of the first drug, the nonbranded versions can come onto the market within five years of the original, although the existence of a patent on the drug often delays that further. After five years, generic manufacturers can ask the Food and Drug Administration for approval to make a copycat product based on the same safety and efficacy data submitted by the original drug maker.

Because patents won’t be as effective in protecting exclusivity against biosimilars, the pharmaceutical and biotechnology industries asked Congress to establish a longer period of data exclusivity for biologics—they originally sought 14 years, based on reports from some economists—before generic makers could use data provided to the FDA from the creator of the product. In June the Obama administration, which is counting on lower-cost generics as a keystone to health reform, said seven years would be a “generous compromise.”

Ethan Guillén, executive director of the Universities Allied group, said the organizations recognized the need for some period of data exclusivity but believed 12 years was too long. “Universities must take evidence-based stances that benefit society, and not simply act as echo chambers for PhRMA and BIO priorities,” the groups wrote in the letter, referring to the chief lobbyists for pharmaceutical and biotechnology companies.

Mr. Vaughn said that the AAU’s position was based on market assessments it found reliable, and that the association had sought a balanced position that would take into account the market realities of the pharmaceutical industry and the needs of the public.

Although many influential parties are playing a role in the debate, Mr. Guillén said the AAU’s withdrawal of support for 12 years of exclusivity could still be significant, both for its symbolism and because it would “remove a fig leaf” that now gives the pharmaceutical industry and others cover to support that many years to monopolize the market.

His group, which has also been working with the AAU and other academic organizations to direct more university research toward improving human health in the developing world, said the association’s position seems to contradict its stance urging universities to be more focused on public health in their licensing practices.

Universities Allied is a coalition of students at more than 40 research institutions in the United States, Canada, and Europe. The medical-student association represents more than 62,000 members, including medical and premedical students, residents, and practicing physicians.

Consumer & Public Health Groups, State Legislators Ask Congress To Oppose Biogenerics Proposal

Today, Essential Action along with the National Women’s Health Network, Community Catalyst, Breast Cancer Action, National Legislative Association on Prescription Drug Prices (NLARx), Knowledge Ecology International (KEI), American Medical Student Association (AMSA) and Universities Allied for Essential Medicines (UAEM) sent a letter to Members of Congress to oppose legislative proposals for the approval of generic biologic drugs that contain excessive periods of data exclusivity or other unnecessary and significant barriers to generic biologic competition.

“Our nation is experiencing massive healthcare costs during an economic crisis,” says the letter. “Increasing the availability of generic biologics will be a critical element of a comprehensive and necessary health care cost containment strategy, and will provide Americans affordable choices in their healthcare. If the wrong legislation passes on this critical issue there will be no generic biologics and patients and a teetering healthcare system will continue to pay the price.”

The letter indicates that the proposal that recently passed the Senate Health Committee, as well as a proposal being floated by Representative Anna Eshoo in the House of Representatives propose excessive amounts of data exclusivity and other unacceptable bureaucratic obstacles to timely, price-lowering generic competition for biologics.

You can read the complete letter in the continuation of this post.
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July 20, 2009

Dear Senator or Representative,

Congressional consideration of healthcare reform has two overriding goals: expand health coverage to the uninsured, and contain costs. It is widely understood that the first goal cannot be achieved absent success with the second objective.

It is therefore vital that Congress take steps to lower the price of the most expensive drug treatments, rather than aid Big Pharma and the biotech industry’s ability to price gouge consumers and the government. For this reason, we urge you to support the Promoting Innovation and Life Savings Medicines Act, H.R. 1427 and reject attempts to pass other biologics legislation that will leave affordable care out of reach.

Over the past twenty-five years safe and affordable generic drugs have been an important option for patients. However, there is an entire category of medicines – biologics – that have no generic alternatives because the FDA does not have the authority to approve them. Biologics are among the most expensive and most important drugs available to patients today. They account for 25% of all new drug products approved by FDA and cost on average 22 times more than chemical drugs. Big Pharma and the biotech companies charge so much more for biologics not because they are more expensive to manufacture, or because research & development (R&D) costs are higher, but simply because they can. Presently, there is no competition in this critical marketplace.

The Senate HELP Committee and Congresswoman Eshoo have put forward legislation that would grant unprecedented data exclusivity periods to brand manufacturers, which will ensure there is long delayed or perhaps even no generic competition. Both proposals, though very different in many ways, would guarantee brand monopolies for at least 12 years and give brands the ability to extend this monopoly even further. The Federal Trade Commission (FTC) has closely examined this issue and released a study stating that any amount of exclusivity is not necessary to protect this industry. The Administration also opposes lengthy exclusivity periods.

Our nation is experiencing massive healthcare costs during an economic crisis. Increasing the availability of generic biologics will be a critical element of a comprehensive and necessary health care cost containment strategy, and will provide Americans affordable choices in their healthcare. If the wrong legislation passes on this critical issue there will be no generic biologics and patients and a teetering healthcare system will continue to pay the price.

While it is disappointing, it is not surprising that one of the most powerful lobbies in Washington has spent considerable resources to ensure that they retain the ability to charge the highest prices that the market will bear. Consumers and the healthcare system cannot bear these prices any longer. We urge you to oppose generic biologics legislation that contains excessive periods of exclusivity or other unnecessary and significant barriers to generic biologic competition. Don’t let big industry interests trump sound public policy.

Yours truly,

American Medical Student Association (AMSA)

Breast Cancer Action

Community Catalyst

Essential Action

Knowledge Ecology International (KEI)

National Legislative Association on Prescription Drug Prices (NLARx)

National Women’s Health Network

Universities Allied for Essential Medicines (UAEM)

Contact Person:
Sarah Rimmington, Attorney
Essential Action, Access to Medicines Project
[email protected]
(202) 387-8030
(Mobile) (202) 422-2687

Big Pharma Close to Hijacking Healthcare Reform with Biogeneric Drug Proposal

For Immediate Release
July 16, 2009

***Statement of Sarah Rimmington, Attorney, Essential Action, Access to Medicines Project***
For more information contact Sarah Rimmington at (202)387-8030 or (Cell) (202)422-2687

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

As the House Energy and Commerce Committee meets to mark up healthcare legislation, it is expected to consider an amendment from Representatives Eshoo and Barton 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, including many or most cancer drugs.Unfortunately, rather than creating robust price-lowering competition, the Eshoo/Barton approach would establish extended monopoly protections — exceeding the monopolies already conferred by patents — and a series of needless bureaucratic hurdles for approval of generics.

President Obama has signalled that in a spirit of “generous compromise” the pharmaceutical industry should be given seven years of monopoly protection for clinical test data — effectively prohibiting generics from entering the market for seven years after a drug goes on the market. The Eshoo/Barton proposal would establish a monopoly period of 14.5 years, and possibly longer. The Federal Trade Commission has concluded that no extra monopoly period is needed to promote innovation or ensure a fair return to brand-name biotech or drug companies.

President Obama’s healthcare reform effort has two goals: to expand coverage for the uninsured, and to control healthcare costs. The Eshoo/Barton proposal would torpedo the objective of healthcare cost containment. The bottom line is simply this: If the Eshoo/Barton approach is adopted, consumers and the government will pay many tens of billions of dollars more in drug costs than needed. Such a windfall for a Big Pharma is something that neither consumers nor the government can afford.”

Essential Action is a public health and corporate accountability group. Our Access to Medicines Project has worked on U.S. and global access to medicines issues for more than a decade. The project focuses on patent and related barriers to generic competition.

Senate Health Committee Votes to Give Extended Monopoly Protections to Biologics

Report by Sarah Rimmington, Essential Action

Late last night the Senate Health committee voted 16 to 7 in favor of a proposal for 12-years of data exclusivity for brand-name biologics that was offered by Sens. Mike Enzi (R), Orrin Hatch (R-UT) and Kay Hagan (D-NC). This proposal was backed primarily by the brand-name biotech and pharmaceutical industry and opposed by consumer groups, a large group of state legislators, unions, several large employers, pharmaceutical benefit management firms, and generic drug companies.

I believe but am unsure that the data exclusivity proposal in the amendment is identical to what was offered in the Kennedy/Clinton/Hatch bill (S. 1695) passed in the committee in the 110th Congress in 2007, but the text has not yet been made available as of the writing of this post, so details are unclear. The FDA approval pathway is said to be almost identical to what was in S. 1695 as well. The Enzi, Hatch and Hagan proposal also added a four year filing moratorium for generic applications (from the date of FDA approval). Reports indicate the exclusivity period in the bill will apply to all biologics passed under the Public Health Services Act starting from their date of FDA approval.

By a 5 to 17 vote the committee rejected an alternate measure backed by consumer groups that was proposed by Sen. Sherrod Brown (D-Ohio). This proposal would have started with a seven-year data exclusivity period, with a limited amount of additional years possible for innovations that require additional clinical trials, and no filing moratorium on generic applications.

The Enzi-Hatch-Hagan proposal was added to the current health care reform bill that the Senate Health committee is close to finalizing. Senator Dodd believes the markup of the bill (which has yet to be officially introduced) can be finalized today or tomorrow. Next the Senate Finance Committee will work on its own version of a bill and then Senate leadership will combine the two bills into one. The full Senate will have a chance to vote on the bill after these processes are finished. It is currently believed there will be a chance to alter and improve the biologics provisions by floor amendment, if it is not or cannot be done in the Finance Committee or by leadership before then.

In the meantime, the House Committee on Energy and Commerce has not yet finalized its version of a biogenerics bill, which will probably be added to its health care reform proposal as well.

Initially the two competing house bills were being considered separately from the health care reform act, but there is a large group of representatives pushing for a brand-name industry-backed bill — H.R. 1548 introduced by Representatives Anna Eshoo (D-CA) and Joe Barton (R-TX)– to be folded into the house health care reform bill. This bill, which offers up to 14.5 years of data exclusivity, is very similar to the Enzi-Hatch-Hagan Senate proposal. In light of the activities in the senate, and in light of the fact the Rep. Eshoo’s bill by her own admission likely has the votes to force its incorporation into the broader health bill, U.S. Congress is coming dangerously close to enacting a bill that will work against their overarching objective of making health care affordable for all Americans.

Energy and Commerce Chairman Henry Waxman (D-CA) and Ranking Member Nathan Deal (R-GA) are backing a competing bill (H.R. 1427) that offers a base of 5 years of data exclusivity. This bill is was endorsed by a large consumer, business, worker and industry coalition. The Obama Administration has recently indicated it supports a “generous compromise” of 7 years base period of exclusivity and that it rejects the call for 14 years.

Despite what has happened in the senate and the strong support so far for the brand-name industry-friendly Eshoo proposal in the house (131 co-sponsors to date), it is not too late to see a consumer-friendly bill passed. There is still time to build more support for the Waxman-Deal biogenerics proposal (H.R.1427) in the House Committee on Energy and Commerce before it votes on the Eshoo-Barton Proposal. Moreover, Congresspersons in both houses will have the opportunity to amend the biogenerics proposals for the better on the floor. We must work to ensure that happens.

For press coverage of the Senate proposal passage last night, see:

* Reuters
* AP
* Wall Street Journal
* PharmaTimes

Essential Action Comments to Canadian Government Regarding How Proposed “Anti-Counterfeiting” Trade Agreement Could Impact Access to Medicines

Today, Essential Action submitted comments to the Canadian government concerning the proposed Anti-Counterfeiting Trade Agreement (ACTA), focusing on the public health priority of ensuring access to safe and affordable medicines to people around the world, regardless of income or wealth.

Download a .pdf version of the comments here: EssentialActionACTAcommentsCanada.pdf

Download a .rtf version of the comments here: EssentialActionACTAcommentsCanada.rtf

A summary of the comments, plus a text version of the complete comments (minus the citations) can be read in the continuation of this post.

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ACTA Comments Summary

Essential Action is concerned that ACTA’s potential public costs are very broad. One broad concern identified regards the lack of transparency of the negotiations, and stakeholder participation. More specifically, the potential public health costs of ACTA are also very troubling. Many of the key elements under discussion could enable policies restricting the availability and free movement of generic medicines. Essential Action urged a deeper analysis and public consultation process regarding their likely effects on global access to medicines.

The potential impact of ACTA on access to medicines include the following:

– ACTA may pile on deterrents against shipping generic medicines that could infringe a trademark or patent in a transit country, even when the products infringe no rights in their port of origin or destination.

More broadly, ACTA contemplates enforcement norms of exceptional reach that would alter existing balances of rights and liability. With respect to access to medicines, the concerns include:

– Leaked ACTA draft texts suggest the Agreement may eliminate the important WTO flexibility of not requiring injunctive relief be available to stop rights infringement, in order to keep health products on the market. Among other harmful effects, this could enable many more detentions and seizures of generic medicines.

– ACTA could legitimize norms favoring widely available injunctive relief for alleged patent infringement, including detentions and seizures of medicines, even though patent status is not reasonably related to drug quality concerns, and generics do not mislead consumers.

– Criminal penalties and damages could be applied too broadly and bluntly, intimidating generics manufacturers (particularly in light of customs officials’ inaccurate infringement assessments, and defendants’ limited recourse to counter infringement claims) and chilling the trade.

– Leaked ACTA draft text states each Party shall provide judges the authority to order alleged infringers to identify third persons in the production chain, such as manufacturers of active pharmaceutical ingredients (APIs) that contract with generics firms. Under such rules, API manufacturers might reason that contracting with generics firms has become too financially risky, and leads to undue invasive scrutiny of their business, and the supply of APIs to generics could dry up. This would undermine generic medicines worldwide.

Perhaps less severe versions of some of these Elements are under consideration. But any of these Elements could obstruct generic competition. Taken together, they would enact a very dangerous and poorly conceived enforcement environment, posing a deeply serious threat to global access to medicines.

ACTA may impose another quite literal cost on the public. Although public laws provide for patent, trademark and copyright protection, it is generally the responsibility of private parties to identify alleged infringements and bring suit. The broad enforcement measures contemplated in ACTA shift the burden of private rights enforcement to the public. This capture of public means for private ends is not only tangential to the legitimate public goals of protecting consumers from unsafe and ineffective products, it may also come at significant financial cost to taxpayers, and divert considerable law enforcement resources from other priorities. A shift in enforcement responsibility implies a change in the very nature of these private rights. It is a potentially major policy shift that should, at a minimum, be subject to serious deliberation in the legislatures of the ACTA Parties.

Another possible public cost relates to innovation incentives and barriers to product development. As Knowledge Ecology International points out, damages rules that enable dramatically increased penalties for infringement and increased availability of injunctive relief, both contemplated in the Elements Under Discussion, could actually hurt innovation, rather than help it. This is because companies developing complex, patent-rich technologies or copyrightable software sometimes infringe, willfully or unwillfully, intellectual property rights in the process. High rents and absolute bars on infringement can make it much more costly, or legally impermissible, to bring these products to market. But sometimes, it is important that infringing technologies reach market.

The comments also discuss ACTA’s present inadequacy to address public safety, and in particular to protect the public from dangerous counterfeit goods, including medicines.

The comments also outline a set of principles for any enforcement policies that could affect the international medicines trade.

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Text version of ACTA comments, not including citations.

Essential Action
P.O. Box 19405
Washington, D.C. 20036

July 2, 2009

Consultations and Liaison Division (BSL)
Anti-Counterfeiting Trade Agreement (ACTA)
Foreign Affairs and International Trade Canada
Lester B. Pearson Building
125 Sussex Drive
Ottawa, Ontario
K1A 0G2

Re: Comments of Essential Action on the Proposal for an Anti-Counterfeiting Trade Agreement

Dear Consultation and Liaisons Division,

Essential Action submits the following comments concerning the proposed Anti-Counterfeiting Trade Agreement (ACTA).

Essential Action is a project of Essential Information, a non-profit organization based in Washington, D.C. We are concerned with protecting the public domain and the information commons. A key organizational area of focus is promoting global access to medicines. While we recognize the proposed treaty implicates many other important issues, our comments focus on the public health priority of ensuring access to safe and affordable medicines to people around the world, regardless of income or wealth.

Transparency and stakeholder participation

As a threshold matter, we note ACTA’s draft text has not been made public, and the publicly available materials regarding ACTA’s proposed subject areas are still thin and too general. This lack of transparency and specificity makes meaningful public consultation difficult, and diminishes the public legitimacy of the proposed agreement.

This is especially true in light of ACTA’s misleading name. While titularly an “anti-counterfeiting” agreement, ACTA in fact seeks to “Establish, among nations committed to strong IPR [intellectual property rights] protection, a common standard for IPR enforcement to combat global infringements of IPR, particularly in the context of counterfeiting and piracy.”

In the public mind and conventional use, the term “counterfeiting” evokes a very different set of concerns – public concerns, including, for example, the safety of consumer goods – than those that can be most effectively and appropriately addressed though the enforcement of private rights, including patents, trademarks and copyrights. ACTA may therefore fail to deliver on the public promise its name implies. Simultaneously, ACTA may confer new protections to private rights holders that could, in fact, come at a public cost. The secrecy of the agreement’s text amplifies this problem of public misrepresentation.

We understand that Canada has stated, at least informally, that it favors making the draft ACTA text publicly available. We request Canada formally and publicly ask its ACTA negotiating partners to disclose the draft text. Such a request would help overcome the problem of negotiating partners insisting they cannot make the text public because they have promised other negotiating countries that it would remain secret. We further request negotiations be placed on hold until a draft text is released.

Additionally, we request Canada formally and publicly support Brazil’s participation as a Party to ACTA, and urge ACTA negotiating parties to open the negotiations to interested developing countries. As we detail below, ACTA rules will likely have significant impact on access to medicines in developing countries, because they may interfere with the legitimate trade in generic medicines, while those medicines are in transit in ACTA countries. Even more importantly, ACTA rules may affect developing countries through its potentially harmful impact on the global supply of legitimate generic medicines.

ACTA’s potential public costs

Approaching anti-counterfeiting policy through private rights enforcement comes with several potential, and potentially serious, public costs.

Global access to medicines depends in large part on market competition reducing prices over time, to levels where government treatment programs can scale-up coverage. Over the last ten years, global competition and generic medicines have produced a revolution in HIV/AIDS treatment, for example, reducing prices from $10,000 to near $100 per person per year, and enabling more than three million people to access lifesaving antiretroviral therapy.

The ACTA Key Elements Under Discussion concerning injunctions, border measures, criminal penalties and enforcement practices suggest the Agreement may facilitate policies that obstruct and deter legitimate generic competition. For example, in several recent incidents, customs authorities in Europe have wrongly detained generic medicines in transit to developing countries, on suspicion of patent or trademark infringement. The medicines were in transit, and did not jeopardize private rights in the country through which they passed. But their detention did disrupt drug procurement in destination countries where, in at least some cases, the medicines were not even on patent. Problems already evident in the European Union could be considerably worsened by ACTA proposals – both binding standards as well as non-binding norms – enabling abuse by rights holders, and chilling investments in the generics trade over time, particularly if appropriate safeguards are not put into place.

Many of the Key Elements Under Discussion could enable policies restricting the availability and free movement of generic medicines.

• ACTA could legitimize seizing in-transit medicines for alleged rights infringements in the transit country, even though such infringements in no way threaten the rights holder’s protected market, because they are merely passing through.

• ACTA may grant customs officials broad authority to seize medicines ex officio – on their own authority – even though customs officials are poorly suited to analyze issues related to intellectual property infringements.

• ACTA may grant rights holders broad authority to trigger detentions, and to keep allegedly infringing goods out of circulation, proposals that clearly open the door to spurious infringement claims and abuse.

ACTA may also pile on deterrents against shipping generic medicines that could infringe a trademark or patent in a transit country, even when the products infringe no rights in their port of origin or destination.

• For example, the Elements Under Discussion contemplate assigning storage fees for detained medicines and legal fees to the alleged infringer.

• It is possible little evidence will be required to trigger detentions, or to support them after the fact.

• ACTA seeks to facilitate the development of public international enforcement networks for private right monopolies, consisting in part of law enforcement officials across the globe who may advise and prepare their colleagues in other countries to stop incoming shipments of generic medicines.

More broadly, ACTA contemplates enforcement norms of exceptional reach that would alter existing balances of rights and liability.

• Under the World Trade Organization’s Agreement on Trade Related Aspects of Intellectual Property (TRIPS) Article 44.2, countries are not required to make injunctive relief – legal orders to stop rights infringement – available in all circumstances, because other important national interests, such as keeping health products on the market, could be compromised. (Rights holders can still sue for money damages.) Leaked ACTA draft texts suggest the Agreement may eliminate this important flexibility. Among other harmful effects, this could enable many more detentions and seizures of generic medicines.

• ACTA could legitimize norms favoring widely available injunctive relief for alleged patent infringement, including detentions and seizures of medicines, even though patent status is not reasonably related to drug quality concerns (described in the next section), and generics do not mislead consumers.

• Criminal penalties and damages could be applied too broadly and bluntly, intimidating generics manufacturers (particularly in light of customs officials’ inaccurate infringement assessments, and defendants’ limited recourse to counter infringement claims) and chilling the trade.

Perhaps even more concerning, Article 2.4 of a leaked ACTA draft text states each Party shall provide judges the authority to order alleged infringers to identify third persons in the production chain, such as manufacturers of active pharmaceutical ingredients (APIs) that contract with generics firms. It is possible liability could attach to such contractors, as well (for example, if they knew or had reason to know the medicines might infringe a patent or trademark, somewhere in the world, even at some point of transit). Under such rules, API manufacturers might reason that contracting with generics firms has become too financially risky, and leads to undue invasive scrutiny of their business, and the supply of APIs to generics could dry up. This would undermine generic medicines worldwide.

Perhaps less severe versions of some of these Elements are under consideration. But any of these Elements could obstruct generic competition. Taken together, they would enact a very dangerous and poorly conceived enforcement environment, posing a deeply serious threat to global access to medicines.

Notably, the Elements Under Discussion do not adequately contemplate important safeguards. These should include, at a minimum and among others, explicitly rejecting patent infringement as a detention trigger, excluding all in-transit medicines from rights-based detentions, adequate procedural protections and provisions for the rights of alleged infringers to be heard, and robust anti-abuse and liability provisions adequate to deter wrongful detentions.

Essential Action is very concerned with the Elements Under Discussion, and urges a deeper analysis and public consultation process regarding their likely effects on global access to medicines.

ACTA may impose another quite literal cost on the public. Although public laws provide for patent, trademark and copyright protection, it is generally the responsibility of private parties to identify alleged infringements and bring suit. The broad enforcement measures contemplated in ACTA shift the burden of private rights enforcement to the public. This capture of public means for private ends is not only tangential to the legitimate public goals of protecting consumers from unsafe and ineffective products, it may also come at significant financial cost to taxpayers, and divert considerable law enforcement resources from other priorities. A shift in enforcement responsibility implies a change in the very nature of these private rights. It is a potentially major policy shift that should, at a minimum, be subject to serious deliberation in the legislatures of the ACTA Parties.

A third possible public cost relates to innovation incentives and barriers to product development. As Knowledge Ecology International points out, damages rules that enable dramatically increased penalties for infringement and increased availability of injunctive relief, both contemplated in the Elements Under Discussion, could actually hurt innovation, rather than help it. This is because companies developing complex, patent-rich technologies or copyrightable software sometimes infringe, willfully or unwillfully, intellectual property rights in the process. High rents and absolute bars on infringement can make it much more costly, or legally impermissible, to bring these products to market. But sometimes, it is important that infringing technologies reach market. For example, developers of new drug diagnostics might overlook a claimed patent or fail to reach a licensing agreement with a patent holder. Injunctions or excessive damages could keep such critical new technologies off the market, or (perhaps more likely) make them more expensive for consumers. Health technologies, especially those developed to treat diseases endemic in poorer countries, are very cost sensitive. If a technology is not cost effective for under-resourced health programs, it might never reach the people it was designed to serve.

ACTA’s present inadequacy to address public safety

First among the public benefits ACTA advertises in its materials is protecting public health and safety from dangerous counterfeit goods. But intellectual property enforcement is a crude, overly broad and under effective tool for protecting these interests. There are more effective and narrowly tailored policies that could be put in place to protect the public from dangerous goods, including substandard medicines – without risking anti-competitive effects.

The Elements Under Discussion do not exclude patent infringement from ACTA’s broad reach. But patent infringement analysis is not reasonably related to counterfeiting or drug quality concerns. The required analyses are entirely separate; one pertaining to alleged use of claimed proprietary inventions, the others to deliberate mislabeling and detailed assessments of drug safety and efficacy. Even a proven patent infringement is no basis for classifying a medicine (or any other product) as counterfeit, under either the TRIPS or World Health Organization definition. Generics are not categorically less safe than branded medicines. Rather than protecting public health, targeting generics through overly aggressive patent enforcement measures, especially without adequate anti-abuse provisions, obstructs competition and could jeopardize access to medicines.

In intellectual property usage, the term counterfeit, as regards medicine, correctly applies only to trademark infringement. But even in the trademark context, only a subset of infringing medicines (or other goods) pose a risk to public health. These include deliberately mislabeled medicines, which fraudulently misrepresent their source or ingredients to consumers. Generic medicines (or other goods) unintentionally bearing symbols or words that could be confused with trademarks cannot be said to pose such a categorical risk.

For this reason, trademark analysis and trademark enforcement is not necessary, and probably not even beneficial, to protecting the drug supply, given that there are better available alternative policies. A better policy would specifically target fraudulent and deliberately mislabeled drugs – irrespective of trademark or any other intellectual property issues. This is indeed a serious public priority.

The possibility of catching some intentionally mislabeled medicines in trademark’s large net may not justify the risk overbroad enforcement policies could pose for access to medicines, given, again, there are more rational and narrowly tailored alternatives. Further, the evidence shows that customs officials overzealously detain medicines that do not, in the end analysis, infringe trademarks. Thus, trademark’s net is probably even larger and less precise in practice than it is in theory. This means an even greater risk to access to medicines. These matters require much more attention and analysis than they have received, before enshrining overreaching enforcement measures in a new global treaty.

Public policy could better protect public health by focusing on mislabeled medicines, rather than intellectual property. For example, countries could require companies to disclose any information they have about potentially dangerous mislabeled medicines on the market. Private companies often have the first or most complete accounts of deliberately mislabeled products, but do not always share what they know.

For example, the Pharmaceutical Security Institute (PSI), formed by fourteen pharmaceutical companies in 2002, recorded 76 cases of counterfeiting in 2004. The U.S. FDA only knew of 58. Some consider PSI’s counterfeiting database the world’s best, yet it “is not accessible to the WHO, health authorities or the public.”

There are at least two existing proposals for statutory disclosure requirements. Cockburn et al. propose a model based on the United Kingdom Civil Aviation Authority’s reporting requirements for suspected unapproved aircraft parts. Companies would be required to report suspected deliberately mislabeled medicines to regulatory agencies. The agency would then take responsibility for confirming the report and deciding whether and when to alert law enforcement and the public. Meanwhile, U.S. legislation introduced by Representative Steve Israel proposed requiring drug companies to notify the FDA within two days of learning of a counterfeit threat. Countries could also commit to sharing such information. Again, disclosure and notification requirements should include appropriate anti-abuse provisions.

Other policy priorities for combating dangerous fake medicines should include strengthening drug regulatory authorities and consumer protection agencies and developing reliable, impartial empirical data on the extent of the medical counterfeiting problem (very little empirical data currently exists), as well as promoting robust legitimate competition to lower prices. There is broad consensus that high prices of some goods drive both supply and demand in counterfeits markets. For example, according to the World Health Organization, “When the prices of medicines become excessively high and unaffordable, patients tend to look for cheaper sources. Such situation [sic] encourages counterfeiters to produce cheaper counterfeit drugs. … When price differences exist between identical products, patients and consumers go for the cheaper ones. This creates a greater incentive for counterfeiters to supply cheap counterfeit medicines.”

Principles; Analysis of ACTA costs and benefits

Under the present Elements of Discussion, the Anti-Counterfeiting Trade Agreement could jeopardize access to medicines, through potential anti-competitive effects, the obstruction of the generics trade, and a high likelihood of abuse by rights holders. At the same time, its method of protecting public safety – aggressive public enforcement of private intellectual property rights – is both over and under inclusive, and may capture some deliberately mislabeled or substandard medicines only incidentally, while aiming to protect pharmaceutical monopolies. Further, ACTA appears to come at significant financial cost to taxpayers, who will be asked to bear the burden of this monopoly enforcement.

There is a critical public interest at stake in the efficient and secure international passage of lifesaving generic medicines. Delays in medicine shipments – to say nothing of their permanent seizure and destruction – jeopardize the health of people awaiting the medicines, primarily in the developing world. Improper seizures of generics put the business model for generic medicines at risk – with potentially serious consequences for access to medicines around the globe.

Essential Action urges, at a minimum, the following principles for any enforcement policies that could affect the international medicines trade:

• All border measure policies must include robust anti-abuse provisions, including strong liability provisions adequate to deter wrongful detentions.

• Rights enforcement policies must include robust procedural safeguards and evidentiary standards to protect medicines manufacturers from costly rights enforcement errors.

• Rights enforcement policies must not compromise generic medicine supply chains.

• Detentions of in-transit medicines should be triggered only by case-specific, legitimate public health concerns – not by private rights.

• Patent status is clearly an improper proxy for drug quality or counterfeiting concerns. Patent status should have no role in decisions to detain or seize medicines, whether in-transit or at their point of destination.

• Trademark violation is not a valid ground for detaining in-transit medicines. Rather, in-transit medicines should only be detained on reasonable, case-specific and good faith belief of public endangerment or fraudulent labeling (the medicines’ packaging deliberately misrepresents identity, source or contents).

Thank you for this opportunity to provide comments. Essential Action is available to discuss any of the aforementioned points in further detail.

Sincerely,

Peter Maybarduk
Staff Attorney
Essential Action

www.essentialaction.org/access
[email protected]

Compulsory Licenses: A Tool to Improve Global Access to the HPV Vaccine?

In June 2009, a paper by Sarah Rimmington and Peter Maybarduk of Essential Action, titled “Compulsory Licenses: A Tool to Improve Global Access to the HPV Vaccine?,” was published in the American Journal of Law and Medicine.

Cervical cancer disproportionately affects women in lower- and middle-income countries. But the new vaccines developed to prevent infection with some strains of the human papillomavirus (HPV) that cause cervical cancer are priced beyond the reach of most women and health agencies in these regions, due in part to the monopoly pricing power of brand-name companies that hold the patents on the vaccines.

Maybarduk and Rimmington conclude that compulsory licenses, which authorize generic competition with patented products, could expand access to HPV vaccines under certain circumstances. If high-quality biogeneric HPV vaccines can be produced at low cost and be broadly and efficiently registered, and if Merck and GSK are unwilling to grant licenses on a voluntary basis, compulsory licensing could play a pivotal role in ensuring vaccinations against HPV are available to all, around the world, regardless of ability to pay.

The authors also note that some of the barriers they identify could pose formidable – and perhaps insurmountable – hurdles to the successful use of compulsory licensing of this one particular product (Merck and GSK’s HPV vaccines) in the near term. Of particular concern are the possible scientific and regulatory challenges to manufacturing and registering generic HPV vaccines (which are biologic products), and the likelihood manufacturing would in any event be concentrated in very few countries. They point out this last challenge could be eased if more manufacturing countries adopt TRIPS Paragraph 6 legislation, enabling them to export vaccines under compulsory license.

However, though barriers to making and using compulsory licenses to ensure the distribution of low-cost generic HPV vaccines may prove insurmountable in the near term, the analysis provided in their paper can still assist governments, humanitarian organizations and others to evaluate the appropriateness of compulsory licensing as a tool to promote access to other life-saving products. For many products, the hurdles will not be so great. Important examples include the prohibitively expensive newer, second-generation drugs for HIV-AIDS, as well as other traditional, chemical-based drugs aimed at additional diseases, which will not face the manufacturing and registration hurdles unique to biologic products like the HPV vaccine.

The context for every product will necessarily be different. But as brand-name companies intensify global patenting, compulsory licensing as a tool to promote access to affordable medical technology becomes ever more important.

Download a copy of the paper here: Rimmington_Maybardukpaper.pdf

Will Venezuela Move to Modify Pharmaceutical Patents?

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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Over the last ten years, generic competition worldwide has produced a revolution in HIV/AIDS treatment, reducing prices from $10,000 to near $100 per person per year, and enabling more than three million people to access lifesaving antiretroviral therapy. Competition and domestic manufacturing have helped Brazil save $1 billion since 2001, and develop one of the world’s most effective HIV/AIDS treatment programs.

Multinational drug companies, based almost exclusively in northern countries, routinely use patent monopolies on key medicines to keep prices at high, anti-competitive levels – often too high to enable widespread treatment, including throughout Latin America.

There are several tailored ways Venezuela could improve access to medicines while contributing to pharmaceutical research and development costs, and complying fully with domestic laws and WTO patent rules. For example, by issuing compulsory licenses, Venezuela could authorize generic competition with specific patented medicines, in exchange for reasonable royalties to the patent holder.

It is not true the Venezuelan pharmaceutical industry uniformly opposes revisions to patent rules. The generics chamber CANAMEGA publicly supports revisions, and domestic manufacturers would benefit from flexibilities allowing them to produce more medicines.

Targeted reforms to Venezuela’s patent system could protect international investment incentives, while also improving market efficiency, increasing investments in innovative research and development – and supporting access to medicines for all.

Civil Society Sends Letter to WHO Expert Working Group on R&D Financing re Transparency and Balance, Conflicts of Interest and Outcomes

Today, Essential Action along with eight other civil society organizations, sent a letter to the World Health Organization Expert Working Group on R&D financing (EWG) to express concerns and make suggestions regarding issues of transparency and balance, conflict of interest and substantive outcomes. The expert working group, which is meeting today in Geneva, was created as the third stage of a longer process to address important flaws in the current system of financing medical R&D. The EWG follows the work of the WHO Commission on Intellectual Property Rights, Innovation, and Public Health (CIPIH) and the WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG). The overall objective of these initiatives has been to reform and change the current system of R&D financing.

Download a .pdf version of the letter here: ngos2ewg_30jun2009.pdf

You can read a text version of the letter below the jump.
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June 30, 2009

Dear members of the WHO Expert Working Group on R&D Financing

The WHO Expert Working Group on R&D financing (EWG) was created as the third stage of a longer process to address important flaws in the current system of financing medical R&D. The EWG follows the CIPIH and the IGWG. The overall objective has been to reform and change the current system. We are writing to express our views regarding transparency, conflicts of interest and EWG outcomes.

1.Transparency and balance

There are no publicly available procedures outlining how EWG will conduct itself. For example, there are no rules for the conduct of meetings and those invited to attend.

The WHO Expert Working Group is this week holding its second non-public meeting. The first meeting in January 2009 was held without advance notice, was not open to the public, and featured attendance and presentations from selected stakeholders, including the pharmaceutical industry, the Gates Foundation and several groups funded by the Gates Foundation – groups that generally share similar views, and which collectively can be said to represent the status quo. There has not been any opportunity for those holding other views to address the EWG meetings directly.

The mode for evaluating proposals is highly secretive. There is little known about which consultants have been hired. The EWG should identify which WHO staff or consultants have been hired to evaluate proposals, and be more open about the proposed criteria, as well as its own meeting schedules and agendas.

While we recognize the need for the EWG to hold non-public sessions, the approach to obtaining stakeholder input should be transparent, participatory and reflective of all views.

There are a number of alternative models to address these concerns for example the public sessions held by the CIPIH.

2.Conflicts of Interest

There are no public procedures on how EWG will address conflicts of interest. This is a critical issue as there are many opposing views.

The pharmaceutical industry, product development partnerships (PDPs) and academic and other non-profit research institutions all will be vying to be recipients of new money for medical R&D. As such, there will be incentives to skew EWG outcomes to favor their institutions. The EWG needs to recognize this, and adopt policies to manage the risks presented by conflicts of interest.

There is also an unusual set of conflicts of interest presented by the Gates Foundation. Today the Gates Foundation is the primary source of funding for many important areas of research and development for neglected diseases, and is also active in setting R&D priorities and norms for a wide range of R&D activities, including the management of intellectual property.

While recognizing and applauding the tremendous good that the Gates Foundation does in many areas, it is also necessary to address openly the fact that in the area of norms for intellectual property, priority setting, and sustainable financing mechanisms, the Gates Foundation is known for supporting proposals and policies that are at odds with some of the most controversial reforms explored in the CIPIH and IGWG processes.

Another recent example of the need for clarity on process and conflicts is the proposal to engage the George Institute to undertake a comparative review of alternative incentives, which will include the establishment of a stakeholder network . In at least one draft, this network would consist of 9 pharmaceutical companies and trade associations, 8 organizations that consist of the Gates Foundation or research organizations funded by the Gates Foundation, 7 government agencies from OECD countries, 5 government agencies from developing countries, and only one NGO critical of the status quo. Such a network would incorporate an unacceptable lack of balance, have many conflicts of interest, lack legitimacy, and be highly unlikely to recommend anything that would represent significant changes.

In addition the proposal mixes into one process, on the one hand core functions of the EWG and stages of review — e.g identification of incentives, establishing the framework for review of submissions, review and short listing; and, on the other the desire to obtain buy-in from certain stakeholders. As a result it gives certain stakeholders privileged prior input into the thinking of the EWG and a key role in setting the parameters for discussion.

3.Substantive Outcomes

It is our view that any proposals in the EWG process should meet the following standards, particularly in light of the recommendations of the CIPIH report and the Global Strategy and Plan of Action.

Sustainable systems of finance for medical R&D, including both sources of funding and possible incentive mechanisms, should be:

1)transparent
2)cost effective, and
3)ambitious enough to address real needs for innovation, and
4)include government funding,
5)require, when possible, open licensing of inventions and other IPR in developing country markets,
6)encourage or require open access to data, material and knowledge,
7)foster the transfer to and development of technology in developing countries,
8)condition financing to requirements for access requirements,
9)promote a range of incentive schemes for research and development including addressing, where appropriate, the de-linkage of the costs of research and development and the price of health products,
10)when possible ensure sustainable and competitive supply of products from generic producers in developing countries, and be
11)accountable to governments and democratic processes.

4.The biomedical R&D Treaty

The recent World Health Assembly, agreed that the EWG should appropriately consider this issue, and report to the WHO. It is very important that the EWG review the proposals made for future discussions regarding a biomedical R&D treaty, including whether to consider recommending that the WHA revisit the question of the WHO role as a stakeholder in discussions about a biomedical R&D Treaty.

Concluding comments

Thank you for considering our comments on these issues and we look forward to your response.

(Groups listed in alphabetical order)

Sincerely:

Jonathan Berger, Senior researcher and head of policy & research: AIDS
Law Project, South Africa

Dr. Oscar Lanza V. Coordinador AIS Bolivia

Luis Villarroel, Director of Research, Latinoamerican Center of
Intellectual Property Research for Development, CORPORACION INNOVARTE

Robert Weissman, Director, Essential Action

German Holguin, Director General, Fundación Misión Salud, Colombia

Tim Reed, Director, Health Action International

Francisco A. Rossi. B. Fundación IFARMA-AIS Colombia

James Love, Director, Knowledge Ecology International

Ethan Guillen, Executive Director of Universities Allied for Essential
Medicines

cc: Sir George Alleyne, Chair, WHO Expert Working Group on R&D Financing
cc: Dr. Elil Renganathan, WHO Executive Secretary for Public Health,
Innovation and Intellectual Property.

Press Release: IP enforcement initiatives threaten consumer rights and public health

The TransAtlantic Consumer Dialogue (TACD), Health Action International (HAI) and Knowledge Ecology International (KEI) hosted a public meeting on the issue of intellectual property rights enforcement in Brussels on Wednesday, June 10th.

Every day we hear about counterfeiting and piracy and about anti-counterfeiting and new enforcement initiatives of governments and industry. HAI, KEI and TACD presented two panels that challenged the direction and rationale of several of these intellectual property rights initiatives, including EU regulation 1383 on border measures and the proposed “Anti-counterfeiting” trade agreement (ACTA). The enforcement of private intellectual property right claims is a complex and important area of public policy that touches on issues such as personal privacy, civil rights, freedom, social and economic development, among others.

European Union leaders and the United States government are currently engaged in efforts to shape global norms for the enforcement of copyright, trademarks, patents and other intellectual property rights. These discussions are taking place in multilateral, plurilateral, bilateral and unilateral fora. Such policies raise concerns because of the delicate balance between on the one hand rights and exceptions, put in place by the international copyright and patent law “acquis”, and on the other hand public health principles such as access to medicines.

Speakers at the event represented consumer and public health organisations from both sides of the Atlantic: Médecins Sans Frontières (MSF), KEI, Essential Action, Electronic Frontier Foundation (EFF), HAI, The European Consumers Organisation (BEUC) and the Brazilian Permanent representation to the European Union, as well as respondents from DG-Trade and DG-Internal Market & Services. The diverse audience included representatives from pharmaceutical, seed, and software companies, the US Chamber of Commerce, academic experts, European Commission officials, members of the European Parliament, journalists, public health groups, consultants, business and civil society organisations.
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Selected quotes by the speakers:

Alexandra Heumber, MSF
“Patent infringement should be excluded from the EU regulation 1383/2003 in order to avoid seizures of legitimate generic medicines in transit.”

“Regulation 3295/94, the law preceding 1383/2003, was much narrower in scope. Rather than including all violations of intellectual property, it focused on counterfeit and pirated goods, which are generally seen as trademark issues. The updated, broader law is problematic as we have seen no justification for the extension to this area and no impact assessment of the effects.”

Eddan Katz, EFF
“At a time when carefully considered public policy is critical for protecting the growth of the knowledge economy, the ACTA negotiations brazenly obscure decision-making in secret meetings outside of public debate and without legislative accountability. The leaked provisions reveal a global information customs regime with radically broad powers for border officials and a grab bag of multi-national corporate lawmaking. As the Internet section is in the process of being mapped onto this border customs pact, the urgency of meaningful public debate demands a release of this ill-considered text.”

Anne-Catherine Lorrain from TACD announced at the meeting that the French Constitutional Court censored the graduated response proposal. The French Court echoed “Amendment 138” of the Telecoms Package voted by the European Parliament, saying that cutting access to the Internet is a sanction that can only be imposed by the judicial authority, taking into account the rights of defense and the presumption of innocence.

James Love, Knowledge Ecology International
“In a plethora of settings, publishers and pharmaceutical companies are pushing an aggressive new agenda to expand and enforce intellectual property rights. The proposals are often advanced in undemocratic and non-transparent fora, such as the top secret and highly classified ACTA negotiations. This is big government and big business at its worst, creating rules without input or sensitivity to the concerns of consumers, overriding civil rights, undermining privacy, increasing prices to consumers. The topics under review are not simple technical issues or directed at organized crime, they are big sweeping changes in our basic freedoms, and underhanded attempts to give lobbyists rules they can’t get in a normal democratic setting.”

Peter Maybarduk, Essential Action
“Many new worldwide measures aggressively protect pharmaceutical monopolies under the guise of fighting counterfeits -­ blocking competition and jeopardizing global access to medicines in the process. For example, the secret, so-called Anti-Counterfeiting Trade Agreement – which in fact focuses on ratcheting-up patent, copyright and trademark protection, with little if any attention to drug quality – deliberately misrepresents its contents to consumers, and is therefore itself counterfeit. Counterfeits are a subset of a much larger drug quality issue. The enforcement agenda fails to address broader quality concerns, and indeed may divert much-needed public health resources away from strengthening drug regulatory authorities. Rather than investing taxpayer dollars enforcing private rights, public bodies should promote price-lowering competition, drug quality and affordable access to medicines.”

Henrique C. Moraes, Brazilian Permanent representation to the EU
“There are ‘TRIPS Plus’ initiatives emerging in fora where these kind of discussions are not expected. Public Interest organisations should be aware of this.”

Kostas Rossoglou, BEUC
“BEUC calls on decision makers in Brussels not to give in to the wish of the content industry to control the Internet. There remains confusion – whether deliberate or not – between consumers and organized operations, whereby consumers are blamed for copyright infringements. Clarification is needed: applying the same enforcement measures to both commercial scale infringers operating for profit and to individual citizens is, at a minimum, disproportionate. While consumers have been actively engaging with the technology and what they can do with it, it is disappointing that many producers and owners of content in the creative industry sector have seen the technology as a threat rather than a business opportunity.”

A Swedish participant at the meeting referred to a quote by MP Johan Linander, Legal affairs spokesperson of the Swedish Center Party, saying “If any of the other negotiating countries still would choose to put a stop to openness, Sweden and the EU will have to seriously consider stopping the negotiations altogether”. This quote is thought to be in reaction to the recent success of the Pirate Party in the European elections.

Panel: EU Accord Threatens India; World Customs Body Scales Back IP Enforcement

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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He cited the Anti-Counterfeit Trade Agreement (ACTA) that the EU, the US, Japan and Switzerland decided to negotiate in 2007 as an example of how several different IP issues are being conflated. There is no clear, universally-accepted definition of what constitutes counterfeiting, he suggested. Whereas the TRIPS agreement focuses on violations of trademarks, the World Health Organization is more concerned with deliberate attempts to mislead consumers about the safety of medicines.

Because of the confusion resulting from this lack of clarity, a number of fallacies have gained currency, he said. “Fallacy number one is that any infringement [of IP rights] can be loosely considered a counterfeit or a pirated good,” he added. “Fallacy number two is that similar remedies can be applied for infringements of distinct rights. And fallacy number three is that aggressively combating alleged IPR [intellectual property rights] infringements protects public health.”

Alexandra Heumber, an access to medicines campaigner for Doctors Without Borders/Médecins Sans Frontières, protested at the series of seizures of generic medicines that have occurred in EU ports in recent times. Seventeen seizures of generic medicines, almost all of which were being shipped from India, occurred in the Netherlands during 2008, according to information released by the Dutch authorities, while a similar seizure also took place in Germany’s Frankfurt Airport last month. In every instance, the medicines were destined for developing countries.

Heumber argued that EU rules set in 2003 give customs authorities the power to intercept legal medicines in cases where it is suspected that an infringement of a patent may have occurred. She urged the EU’s executive branch, the European Commission, to issue new guidelines making it clear that such seizures should not be applied to generic medicines.

“While the seizure of counterfeit drugs is understandable, the seizure of legitimate drugs in transit is not acceptable,” she said.

Patrick Ravillard, a trade official with the Commission, said that his institution does not “make any confusion between generic medicines and fake medicines.” Stating that the EU is committing to boosting access to medicines for the poor, he said that assurances have recently been given by Europe’s leading pharmaceutical firms that they will not invoke EU rules to request the seizure of generic drugs. Such assurances are “very positive,” he claimed.

James Love from the organisation Knowledge Ecology International attacked the lack of transparency surrounding the ACTA negotiations. Documents under discussion and even the names of those taking part in the talks have been withheld from the public. He also suggested that leaks from the talks indicate that the title ACTA is something of a misnomer. Rather than being confined to matters of counterfeiting, the talks are dealing with a variety of other intellectual property issues, with the EU even seeking to place geographical indications (terms such as Bordeaux or Champagne that belong to food or drink from particular locations) on the agenda.

WCO Scales Back Policymaking on IP Enforcement

Meanwhile, Brazilian diplomat Henrique Moraes said that public interest groups should be wary of a phenomenon known as “forum-shopping” by governments where IP issues that have been rejected in one institution appear on the agenda of another.

The little-known World Customs Organization, he noted, has been discussing proposals aimed at allowing customs authorities throughout its 174 member countries to seize goods in transit when it is suspected that patents may have been breached. Such provisions went beyond the scope of TRIPS, he added.

Protests raised by Brazil and some other developing countries appear to have paid dividends, he added. During discussions held last week, it was agreed that the WCO will replace its working group known as SECURE (Standards to be Employed by Customs for Uniform Rights Enforcement) with a new internal body. Unlike SECURE, its successor, the counterfeiting and piracy group, will be restricted to exchanging information on how customs officials deal with IP issues and will not have a mandate to set norms or decide on best practices.

[1] http://www.bilaterals.org/article.php3?id_article=14864