Johnson and Johnson Non-Assert Agreement on Darunavir - More Questions than Answers

by Professor Brook K. Baker, Senior Policy Analyst

Janssen Pharmaceutical Company, an affiliate of Johnson & Johnson, has just announced its intent "not to enforce its patent for quality, medically acceptable generic versions" of its protease inhibitor, darunavir (brandname Prezista) for sales in sub-Saharan Africa and in UN-defined Least Developed Countries.  That restriction gives this so-called "non-assert" commitment a geographical scope of just 64 countries. 

Janssen's publicity release is intended to give it a reputational boost on the eve of World AIDS Day, but there are multiple deficiencies and ambiguities in its announcement.  Although any increased access to generic darunavir of assured quality is desirable, Janssen has given far less than what is required:

  1. The geographical scope is woefully inadequate because it excludes treatment-experienced patients in all non-African middle-income countries who are much more likely to need second- and third-line medicines – like darunavir – because they've developed treatment resistance to other regimens over time.  The vast majority of patients in developing countries who are treatment experienced and who need second- and third-line regimens live in middle-income countries in Latin America and Southeast Asia where patients first had government supported access to treatment, e.g., Brazil and Thailand.  Excluding these middle-income countries not only leaves poor patients in middle-income countries subject to the pricing whims of Janssen, but it also shrinks the market of darunavir-eligible patients.  Accordingly, the resulting consumer demand will be too small to incentivize robust generic competition and economies-of-scale will be much slower to develop – resulting in higher prices and fewer sources even in the covered territories.

  2. The "generosity" of the geographical scope is misleading, because it appears that Janssen has no patent claims whatsoever in the vast majority of countries covered by the non-assert commitment.  A search of the Medicines Patent Pool patent database reveals a patent for a darunavir pseudopolymorph in ARIPO (Botswana, Gambia, Ghana, Kenya, Lesotho, Malawi, Mozambique, Sierra Leone, Sudan, Swaziland, Uganda, United Republic of Tanzania, Zambia and Zimbabwe) and in South Africa only.  Of course, there may be additional patents that have been filed, but to date Janssen, like virtually every other Big Pharma company has been unwilling to publicly disclose their existing patent landscape in developing countries, making it very hard to generic competitors, governments, or other interested parties to ascertain patent status.

  3. The prices currently charged in excluded, non-African middle-income countries can be quite outrageous.  According to MSF and Global Fund data available at http://www.theglobalfund.org/en/procurement/pqr/,  prices being paid by some excluded countries are as follows:
    Brazil:  USD 6,037 ppy
    Georgia: USD 8468 ppy
    Moldova: USD 9187 ppy
    Jamaica: USD 6570 ppy
    West Bank and Gaza: USD 5900 ppy
    Thailand: USD 4854 ppy 
    Of course, these prices are for one component of triple-therapy only, so the aggregate cost of a full second- or third-line regimen in these countries could be many times higher.

  4. Janssen has not clarified whether the non-assert commitment is absolute and for the duration of any relevant patent claim or whether the commitment could be revoked.  In press coverage on the commitment, Janssen has already indicated that there are circumstances where it would assert its patent rights if - in its unilateral judgment - darunavir was being produced in sub-optimal formulations or dosages.  This would leave little incentive for generic companies to try to optimize chemical form, formulations or dosages since the rug could be pulled out from under it both with respect to the original investments needed to produce darunavir at all and with respect to the additional expenses incurred to "optimize" the medicine.

  5. Janssen has not clarified whether it will permit co-formulation with other medicines, though as a protease inhibitor darunavir needs to be combined with a protease booster such as ritonavir.  In addition, darunavir should, if possible, be co-formulated with the other medicines to produce a fully potent fixed-dose combination.

  6. Janssen has not clarified where the darunavir for covered countries can be lawfully produced.  There is a weak and opposed divisional claim for a combination with ritonavir in India and Janssen is pursuing an appeal of a denial of its patent for darunavir as a stand alone product.  Thus it is not completely clear in the long run that India companies could produce a darunavir standalone or a ritonavir/darunavir combo for export to SSA and LDCs.  Since the major generics of assured quality ARVs are India-based, it would be highly desirable if all generics producers of assured quality, including Indian, were permitted to produce for export.

  7. Janssen has not taken adequate steps to ensure registration of darunavir in the covered territories despite ample time to do so.  The absence of such pre-existing registration negatively impact the cost, timeliness, and ease of registering a generic equivalent.  Many of the covered territories will allow fast-track registration of generic equivalents, but only if the originator's dossier has already been approved.  In the same vein, Janssen has failed to clarify whether it will assist in the generic registration process, and whether it will waive any data rights or patent-registration linkage rights in may have in any of the covered territories.

  8. Janssen has not clarified what if any restrictions it might place on "qualified" generics, e.g., with respect to their right to oppose patent applications or challenge granted patents or to be licensees of compulsory licenses granted in non-territories.  There may well be other non-disclosed terms that are problematic.

 

The ideal voluntary license is one that is open to all qualified generic producers and has a territorial reach of all developing countries.  The closest to that ideal at present is the Medicines Patent Pool, which has the added advantage of transparency about licenses and efficiency in acting as a clearinghouse for multiple licenses on diverse products.  However, for the second time, Johnson & Johnson has tried to cover its tracks in boycotting the MPP by saying "we feel better doing it alone."  Indeed, J&J has stepped back from its earlier 2011 voluntary license because the geographical scope on this second commitment is smaller than what it promised a year ago for rilpirivine.   

 

In sum, the limitations on the Johnson & Johnson/Janssen non-assert commitment make it a gift box without the gift on the even of World AIDS Day.  Yes, over the long haul, as demand in the covered territories builds, a viable generic market may slowly develop and generic companies may get through the arduous registration process unassisted.  But, many other patients in middle-income countries and in underserved SSA and LD countries will go without the life-enhancing and life-saving benefits of darunavir in the meantime.  Scarce resources will be wasted on overpriced brandname Prezista or patients will go without.  This frankly is not good enough.


A small sales tax on Wall Street reaps big rewards

One has to wonder if Paul Schott Stevens’ “Don’t enact financial transaction taxes,” December 20, 2012, is more about protecting the turf of billion dollar Wall Street banks and enormous investment firms, including their lucrative mutual fund businesses, than protecting the average people who invest and save.  

In his column, Stevens argues against the enactment of a financial transaction tax (FTT) in the U.S., as follows: “[A]ny benefits … would be dwarfed by the harm it would inflict on America’s savers, particularly its 90 million mutual fund shareholders.” Stevens is president and CEO, Investment Company Institute (ICI), a trade association comprised of more than 7,500 mutual funds, with names like Wells Fargo CoreBuilder and Morgan Stanley Global, as well as other investment entities.

What’s raised Stevens’ ire of late is legislation introduced in Congress in September by Rep. Keith Ellison (D-Minn.), H.R. 6411, “The Inclusive Prosperity Act,” an FTT now with 16 co-sponsors and the backing of the Robin Hood Tax Campaign, a coalition in the U.S. of more than 125 labor, religious, consumer, health advocacy and other groups, with combined memberships in the many millions. 

Scores of leading economists and businessmen support passage of an FTT, as they, too, see it as a legitimate way to raise revenue. Backers include Bill Gates, Warren Buffett, David Stockman, Nobel Prize-winning economists Joseph Stiglitz and Paul Krugman, to name several.

The fact is that for the majority of Americans Ellison’s FTT should cost nothing, hence Stevens’ principal contention that FTTs “will produce a constant drag on shareholder returns… [and] make it all the harder for fund investors to achieve retirement security and other goals” is very misleading. 

HR 6411 is a tiny tax; it is 50 cents per $100 on stock trades - that’s $50 on a stock trade of $10,000 - and even lesser rates on bonds, derivatives and currency dealings. Here’s what’s critical, and conspicuously absent from Stevens’ column: the facility or broker is levied the tax, not the investor. Thus Stevens’ argument that an FTT constitutes double, triple, even quadruple taxation is way off base.  

Here’s the rub for investors: The sales tax is paid by the investor only if the mutual fund passes it along. We would urge the mutual funds Stevens represents not to pass along this small sales tax to the very savers whose interests Stevens says he seeks to guard.

The point here is that mutual fund profits are more than ample to absorb this very tiny tax. Just look at the billions in wealth gathered by top mutual fund managers. According to Forbes, Fidelity Investments’ chairman is worth $11 billion; Charles Schwab’s wealth is approaching $5 billion, some attributable to fund activity; and Charles Johnson, chairman of Franklin Resources, has made $4 billion from his mutual fund business.

As a final protection to investors, per the Ellison law Americans with incomes of up to $50,000, $75,000 for households, would be rebated any FTT paid.   We do not share Stevens’ concern that a tax rebate is an unworkable administrative burden, as credits and rebates are hardly new concepts.

Stevens’ worries extend overseas, where the European Commission, he points out, is moving forward on a unified FTT scheme, with the support of 11 member countries. Forty countries now have some FTT in place. As for the U.K. and its decision to stay out of the EC scheme, we would reiterate that a tax on stock trades – the Stamp Tax - is in place in that nation and the London Stock Exchange remains one of the biggest in the world — even with an FTT on stock transactions.

A unified scheme in Europe and around the world, at all the major exchanges, avoids capital flight. So when Stevens raises that issue in the context of Sweden a generation ago, he seems behind the times.

In France, cautions Stevens, “large players are able to skirt the tax using an array of techniques, leaving small investors to bear the burden.” Unlike many taxes, Ellison’s proposal is difficult to evade because the tax is collected at the point of transaction and title is withheld until marked paid. With automation, trades are easy to track and tax collected. 

Stevens shares our concern that “high frequency trading” needs regulation, but he believes an FTT  “seems an awfully blunt tool for achieving that goal.”  But the same top economists who support the FTT cite its usefulness in helping curb these destabilizing trading practices. 

By one estimate, for every gallon of gasoline purchased in the U.S. today, $1 of cost can be attributed to speculative activity in the markets. We think that’s a national shame. An FTT can help to lower levels of speculative trading, according to numerous studies.  

To the  millions of Americans who are members of organizations calling for an FTT, some of whom are also mutual fund investors, the Ellison bill’s goal of raising an expected $350 billion annually serves an overwhelming national need. The FTT would expand state and federal investments in communities still very much experiencing harm from the 2008 financial collapse. The Inclusive Prosperity Act identifies job creation, the rebuilding of infrastructure, investment in transportation, education and healthcare, and environmental protection among its goals. It would also direct funds to international research and treatment of HIV/AIDS and to address climate change. 

FTT supporters believe there is no time to delay, as the enduring harm faced by countless communities drags America deeper into poverty and forestalls a real recovery.

Given the amounts our Treasury expended on Wall Street bailouts, not to mention substantial profits racked up in the finance sector today, an FTT at these small rates and under these well-defined conditions seems eminently fair. Wall Street’s debt to Main Street is past due.

Jennifer Flynn is managing director, Health GAP, a founding member of the U.S. Robin Hood Tax Campaign.

Source: 
http://thehill.com/blogs/congress-blog/economy-a-budget/276119-a-small-sales-tax-on-wall-stree-reaps-big-rewards


Health GAP's 2012 Redux: Help us, help you...

We began 2012 with a bold commitment from President Obama to “create an AIDS free generation”.  This vision for policy was rooted in science and was heralded by advocates.  This new direction towards an AIDS policy deeply rooted in science was strongly advocated by Health GAP.  The campaign to get us there consisted of a series of small, seemingly disparate, actions which enabled us to slowly build key relationships, power in crucial legislative districts and a strong reputation with media and advocacy organizations.  This combination of an “inside and outside” strategy is Health GAP’s formula for success and we are writing to ask you to support our work in 2013.

Here are some of the highlights that Health GAP achieved in 2012:

  • Health GAP spearheaded the We Can End AIDS coalition which organized tens of thousands of people living with AIDS for a massive mobilization in Washington, DC during the International AIDS Conference directly confronting decision makers on their global AIDS response and setting the tone for the conference.
  • Health GAP is leading the U.S. Robin Hood Tax campaign to demand a tiny tax on big banks that could raise enough money to end AIDS.  We launched the campaign with a celebrity filled video.  Within a few months, the campaign successfully advocated for the introduction of bold legislation that could generate up to $350 billion per year to fund our social safety net.  (For more info goto www.robinhoodtax.org)
  • With the recognition that no social justice movement has ever been successful without a strong youth base, our student organization, the Student Global AIDS Campaign launched the Positive Students Network in an effort to intentionally organize HIV+ youth in high school and college campuses across the country.  (For more info, go to www.studentglobalaidscampaign.org)
  • Health GAP Uganda worked with SumOfUs.org to develop a petition targeting Pepsi, one of Uganda’s largest employers, to speak out against the proposed homophobic legislation that calls for the death penalty of LGBTI generating over 100,000 signatures.
  • Thanks in part to the advocacy of Health GAP Kenya and our partners, Kenya has increased the investment in their domestic health budget by 55% and is the only high-prevalence/low-income country to get one person on treatment for every new infection.
  • Health GAP, working with QUEEROCRACY and ACT UP Philadelphia, “exposed” the “naked” truth about the proposed dramatic budget cuts that could result in the death of 62,000 people living with AIDS.  Our work generated an unprecedented amount of media attention.  See http://www.cnn.com/video/#/video/bestoftv/2012/11/28/exp-point-protestors-boehner.cnn

Health GAP is a small organization with almost no overhead.  Your donation is tax exempt and goes directly to support our effective advocacy.  If you can, please donate today and join our movement:  www.healthgap.org.  Thank you for your time, consideration and commitment to ending the AIDS pandemic.


A Civil Society Call for IMF Reform

November 11, 2008 

The financial turmoil that originated in the United States a year ago has become a global financial crisis widely believed to be the most severe since the Great Depression. The foundations of financial markets – previously thought of as almost invincible – have collapsed, 

plunging the world into a recession that is severely impacting emerging market countries whose financial markets are inextricably tied to those in the West, as well as low-income countries who are already suffering the impacts of higher food and oil prices. In the wake of the current global financial crisis, the International Monetary Fund (IMF) is signing new multi-billion dollar loan deals across both developed and developing countries. With an almost sudden force, it has emerged out of the “irrelevance” it was accused of in recent years and has reacted by positioning itself as the “financial firefighter” for a diverse range of countries teetering on the brink of financial meltdown. After having been portrayed as obsolete in a new world economy defined by the economic muscle of emerging markets, the IMF is now being heralded by media headlines that read: “The IMF is back in business” and “The Fund is back in town.” 

U.S. civil society organizations that work on international development, HIV/AIDS, global health and labor rights issues agree that there must be a fundamental change in the content and application of the IMF's policy conditionalities and policy advice. We call for structural 
policy changes to eliminate IMF-mediated macroeconomic targets that negatively impact long-term national development and growth, and to reduce the scope of the Fund's policy prescriptions so that it does not venture beyond its institutional mandate. We also call for debt cancellation and the adoption of international best practices in governance, transparency and inclusivity. 

Specifically, the following principles and policies should be adopted as the role and functions of the IMF are reshaped. 

The IMF should exit the development business
The IMF does not have policy expertise in the development arena, and its policy interventions in development-related policy have been harmful. Aid should be channeled through appropriate multilateral and bilateral development agencies, not the IMF. The IMF should also not be in the business of maintaining programs intended to signal to donors which countries should be eligible for foreign aid assistance. The IMF’s unique role in the market for macroeconomic assessment leads to a monopoly—this should be opened up in order to create competition in the market and ensure development principles such as country ownership and stakeholder participation. Accordingly, the Poverty Reduction and Growth Facility (PRGF) and the Policy Support Instrument (PSI) should be closed, and the funds in the PRGF trust should be shifted to the trusts of aid agencies, implying no net decrease in concessional resources available to low-income countries. 

Eliminate the IMF's mission creep 
The IMF should not attach policy conditionalities or offer policy advice that is unrelated to addressing balance-of-payments problems directly. As the Independent Evaluation Organization's report on structural conditionalities stated, IMF's policies should be refocused to 
its circumscribed "core competencies" such as public expenditure management and tax 2 administration. The Fund should not venture into areas such as privatization, labor market regulation and trade liberalization. 

Debt cancellation 
Debt cancellation should be expanded to all the world's most impoverished countries (IDA only) without harmful conditions. The serious hardships imposed on middle- and low-income countries by the global financial crisis demand such a move. As international agencies and lenders prepare to ramp up what may be hundreds of billions of dollars, or more, in financial flows to developing countries, the financial feasibility of immediate debt cancellation for poor countries is clear. Furthermore, the increasing debt levels in developing countries over the past year are not the consequence of domestic policy failures, but rather are the result of exogenous causes including 
shocks in energy and food prices and now erosion of export earnings because of financial turmoil originating in developed countries. Developing countries should not have to shoulder the financial burden of debt that has been caused by exogenous and imported crises. 

No financial sector liberalization 
Given the financial crisis, IMF programs should not demand or encourage financial sector liberalization. Countries must be free to employ capital controls and other modes of regulation to the capital accounts in order to buffer extraordinary capital outflows and inflows. According to latest data, capital flows from Western financial institutions to emerging markets plunged from $900 billion to a mere $56 billion this year (6% of last year's amount). Clearly, this hemorrhaging of financial resources legitimizes capital account and exchange rate regulations as well as other measures by the state to intervene in national financial markets in the same manner that Western countries such as the United States have acted. 

Let developing countries pursue expansionary macroeconomic policies 
Countries must be free to pursue expansionary economic policies. It does not make sense to pursue restrictive policies to redress inflation caused by currency devaluations that are largely unrelated to any domestic policy. Similarly, in a time of global recession, countries must be free to run fiscal deficits, in order to build national demand and meet important social needs. Most developing countries' inflation is a result of imported or exogenous sources of inflation in global commodity markets. In the global financial crisis and world economic recession, tightening fiscal-monetary policies is not only the very opposite of what the G-7 countries have been doing – injecting liquidity into their financial institutions and loosening their monetary policies – but it is also clearly unjustifiable in terms of the harms caused to advancing development. Existing IMF policies need to be re-examined and revised toward instituting fundamental changes to the 
design, implementation and theoretical rationale behind the Fund’s macroeconomic targets regarding inflation and fiscal deficit levels. 

The IMF should not impede public spending through budget caps 
Specifically, the IMF must not impede countries from expanding government spending—free from any overall budget caps or overly restrictive fiscal deficit targets—on activities primarily involving domestic inputs. These include most importantly services such as healthcare and education. Increased domestic spending in health and education is especially important in times of recession, as low-income countries are even less able to afford essential services. The potential risks of IMF signaling to donor agencies about alleged increases in national macroeconomic instability, as defined by the IMF, is all the more apparent in the context of the 3 global financial crisis. Consequently, it is all the more important to drop the IMF’s overly restrictive macroeconomic targets of inflation below 5% and fiscal deficits below 3%. This will require political will and concerted action. 

IMF policies need to generate decent work 
The IMF must also address the crisis in economic inequality, which is at the root of the current financial crisis. In both developed and developing countries, worker productivity has steadily increased while real wages have failed to keep pace. The IMF must abandon policies that choke off job creation; and should instead be supportive of macroeconomic and labor market initiatives designed to promote jobs founded on the International Labor Organization (ILO) concept of Decent Work. Further, there should be a strong commitment to the provision of publicly financed public services, performed by public employees. 

Transparency and access to information at the IMF is vital 
Transparency and the right to access information must be strengthened at the IMF. Disclosure of IMF draft policy papers, technical assistance reports, and Executive Board documents – such as the minutes of Board meetings – is imperative to facilitating informed participation by external stakeholders in national economic decision-making and to ensuring citizens' ability to hold their 
governments accountable. 

Participation must open up 
IMF practices must change to ensure national, democratic decision-making over policymaking. The operational process of IMF Mission Teams that visit countries to review loan agreements or conduct annual surveillance (Article IV reports) must facilitate open and informed consultations with a wide range of external stakeholders, not just with the Ministry of Finance and the Central Bank. Stakeholders should include other relevant government ministries (including health and education), independent economists and academic specialists, national civil society and labor unions. In particular, parliamentarians should have the right to view and discuss every loan program document before they are signed by the national finance ministries and central banks. These broad and meaningful consultations should occur before a country's macroeconomic policies are set. 


Endorsing organizations: 
ActionAid International, USA 
AFL-CIO 
Bank Information Center (BIC) 
Essential Action 
Gender Action 
Health Alliance International 
Health GAP (Global Access Project) 
Jubilee USA Network 
RESULTS 
Treatment Action Group (TAG) 

For more information contact: 
Asia Russell, Health GAP, asia@healthgap.org, (267) 475-2745



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