A round-up of news about access to treatments, with links to sources
29 July 2004. Related: Treatment alerts.
Graham McKerrow, HIV i-Base
US trade deals threaten access to medicines
Trade deals being negotiated between the United States and individual countries or regional groups could severely restrict access to essential medicines for millions of people around the world according to the international medical humanitarian organisation Medecins Sans Frontieres (MSF). MSF warns that the negotiations are part of a US strategy to build a network of agreements that undermine international consensus reached at the World Trade Organization (WTO) about the appropriate balance between the protection of private intellectual property and the protection of public health. These agreements will make it impossible for dozens of countries to ensure access to affordable medicines for their populations.
The MSF reports says: “After being forced to compromise in multilateral negotiations, the United States has turned its attention to regional and bilateral free trade agreements (FTAs) that will affect every region of the world. These bilateral and regional agreements are attracting little public attention, are often highly technical in nature, and are being negotiated in secret, despite repeated requests from civil society to open them to public debate. The United States’ goal in such negotiations reflects the wishes of the group of industry representatives advising the US Trade Representative.”
Links to the report “Access to Medicines at Risk Across the Globe: What to Watch Out for in Free Trade Agreements in the United States”
USA and multinationals move to introduce fixed dose combinations
The US Food and Drug Administration (FDA) and several of the world’s biggest pharmaceutical companies issued statements on the same day in apparently coordinated moves to outflank the smaller generic producers by planning to market drugs made by different companies in single pills, or as separate pills distributed together in the same packages. The announcements refer to providing treatments to developing countries, and the US government statement is explicit that this will be part of the United States’ multi-billion dollar programme to tackle HIV in certain specified countries. The multi-drug pills are called Fixed Dose Combinations (FDCs) and having pills with different drugs in the same packages is referred to as ‘co-packaging’ or ‘co-blisters’.
By offering FDCs the generic manufacturers are able to provide not only cheaper treatments but also treatments that are more effective because they are easier to take and therefore adherence is likely to be better. There have been demands dating back several years for the multinational pharmaceutical companies to produce FDCs but to no avail. It is only since the production of FDCs by the generic manufacturers and the availability of billions of dollars, from the US government and the Global Fund to Fight Aids, TB and Malaria, that the pharmacos have acted on this issue.
Below are summaries of the announcements and links to the full statements.
FDA process for fast track Fixed Dose Combination (FDC) approval
The US FDA announced on May 16 a guidance document that describes a process to expedite approval of co-packaged and fixed dose combination (FDC) therapies “so that high quality drugs can be made available in Africa and developing countries around the world under the President’s Emergency Plan for AIDS Relief.”
The new process simplifies procedures for submitting clinical safety and efficacy data, virology, chemistry and bioavailability information for treatments. A marketing application cannot be approved to permit sale in the United States until relevant patents or exclusivity protections expire, but the FDA could grant “tentative approval,” showing that a product had met all FDA scientific standards for safety, efficacy, and quality. Such tentatively approved products would then be available for procurement under the $15 billion President’s Emergency Plan for AIDS Relief.
Link to the Federal Register Notice, Availability of Guidance:
Link to the draft Guidance Document:
Details of the FDA announcement can be found on the US government website:
On the Net:
FDA AIDS site:
MSF says new procedures sidestep international standards
Médecins Sans Frontières has criticised the new US procedures for approving FDCs and co-packaged medicines, saying that rather than creating “a unilateral system which unnecessarily complicates and delays matters”, the US should support the existing World Health Organisation prequalification system, and lend the technical expertise of FDA officials to the process.
A statement issued by Rachel M Cohen, US Director of the MSF Campaign for Access to Essential Medicines, says: “The US has repeatedly been invited and encouraged to take part in the prequalification project and has consistently refused to collaborate.
“It is the World Health Organisation, and not the US Food and Drug Administration, which has the mandate to set international standards for quality, safety, and efficacy. There is no justification for further delaying the availability of medicines that are already saving lives and that are already certified by the WHO as meeting stringent international standards for quality, safety, and efficacy.”
The full MSF statement is at:
Gilead, Merck and BMS announce plans for FDC
A joint announcement was made on May 16 by Bristol-Myers Squibb, Gilead Sciences and Merck saying that the three companies were in discussions on the development of a once-daily, fixed-dose combination of three anti-HIV drugs and were also considering co-packaging options for the individual products.
The potential three-drug, fixed-dose combination would include two Gilead drugs, Viread (tenofovir disoproxil fumarate) and Emtriva (emtricitabine). In March, Gilead filed applications in the United States and Europe for approval of a single-tablet formulation of these two drugs. The third drug in the proposed combination, is efavirenz, which is marketed in the United States, Canada and certain European countries by Bristol-Myers Squibb as Sustiva and elsewhere by Merck under the brand name Stocrin.
The companies also are discussing a co-packaged version that would include the three products as an interim step until a fixed-dose combination product could be made available.
Although joint company collaborations are to be welcomed and patients in the West will be able to be able to benefit from the lead taken by generic companies, it is difficult to know how with current formulations this resulting FDC could be compressed into one pill. In this case the options of two pills QD will already be available in the existing formulations.
Boehringer and GSK announce co-packaging talks
Boehringer Ingelheim and GlaxoSmithKline issued a joint statement in Ingelheim, Germany, and London, UK on 16 May saying “both companies welcome the United States’ continued involvement in the global response to HIV/AIDS”. Boehringer Ingelheim and GSK have entered into discussions to assess the development of co-packaging of anti-retrovirals for the treatment of HIV infection in the developing world.
The full statement is at:
The world health report 2004 – changing history
A World Health Organisation report, Changing History, calls for a comprehensive HIV/AIDS strategy that links prevention, treatment, care and long-term support. At a crucial moment in the pandemic’s history, the international community has an unprecedented opportunity to alter its course and simultaneously fortify health systems for the enduring benefit of all, says the WHO
The report comments that by the end of 2004, WHO will have achieved only 25% of the “3 by 5” target but many believe the figure that 25% is itself overly optimistic.
Among all possible HIV-related interventions, the report says it is treatment that can most effectively boost prevention efforts and in turn drive the strengthening of health systems and enable poor countries to protect people from a wide range of health threats.
WHO world health report:
WHO press release:
Cote d’Ivoire activists angry at slow disbursement from Global Fund
Activists are angry that six months after Cote d’Ivoire received a US$91 million grant to fight the disease, not a penny of the money has been spent fighting the spread of HIV or helping those living with AIDS. The first tranche of $28 million from the Global Fund to fight AIDS, TB, and Malaria was made available to the government of Cote d’Ivoire in December last year after being held up by several months of infighting between different ministries over who would get to spend it.
The representative of one Ivorian non-governmental organisation (NGO) said: “Projects have been submitted to the committee that is coordinating how the funds will be spent, but nothing has been done yet.”
The representative of another Ivorian AIDS NGO, who was equally unwilling to be named, pointed out that Cote d’Ivoire had also received $2.5 million to fight AIDS from the United States and $760,000 from Belgium over the past year, but this money too had yet to be spent.
“The AIDS epidemic is getting more money that anything else in Cote d’Ivoire, but you can’t see its impact on the ground,” he complained.
The full text of the report by the UN Office for the Coordination of Humanitarian Affairs 2004 is at:
700 PLWA in Panama face ‘death by bureaucracy’
Unbelievable as it seems, 700 People Living with HIV/AIDS (PLWA) in Panama have been without their anti-retroviral treatment for over two months due to bureaucratic “errors”, report Richard Stern and Guillermo Murillo, of the Agua Buena Human Rights Association
Most of these 700 people receive ARVs through the Panamanian Ministry of Health at one major inner city hospital and come from the country’s working classes, and informal labor force, and are therefore among the nation’s most impoverished people. Meanwhile, 1,100 employed middle and upper class PLWA who receive treatment through the government run but semi-autonomous “Social Health Institute” continue to receive their treatment care system.
Dr Gladis Guerrero, National AIDS programme director, acknowledged that because of “human error,” the Health Ministry program failed to carry out purchases to ensure continued treatment for those who receive their ARVs through its programmes. Dr Guerrero would not say when the problem was expected to be resolved, only that she hoped that it would be “as soon as possible.”
The full article is at:
20 of the world’s 41 richest nations have promised nothing to the Global Fund for 2004 and 2005
Aidspan, the US-based independent watchdog that follows the work of the Global Fund to Fight AIDS, TB and Malaria, says that almost half of the 41 richest nations have not promised a dollar to the Global Fund for this year or next year.
The group analysed the Equitable Contributions Framework, which was drawn up in 2002 to decide the level of contributions each country should make to the fund. They found that only 14 countries have given 100% of their equitable share.
Aidspan worked on the basis that the Global Fund declared that it needs at least $1.4 billion this year and $3.3 billion next year. They followed the proposal made by President Jacques Chirac of France and others and accepted by the US Congress, that the USA should provide one third of the total, Europe should provide a third and the rest of the world should give the final third. Within each ‘third’ the donations should be in proportion to the countries’ gross national product (GNP). Aidspan looked at the records of the 41 countries that are defined by the World Bank as “high-income”.
Only two nations, France and the Netherlands, have promised 100% or more of their equitable share for both years.
The good news is that the total promised to the fund for this year is $1.515 million, which is slightly higher than the $1,400 million goal. More than half (53%) of the 2004 money has come from the EU nations, which have 27% of the world’s GNP, 36% from the USA, which has 32% of the world’s GNP and 11% from the rest, which have 41% of the world’s GNP, although half of this GNP share is attributable to more than 100 non-high income countries.
Total money promised for next year is $842 million, which is only 26% of the $3,300 million needed. This has come 69% from the EU nations, 24% from the US and 8% from the rest.
There are four high-income countries that are represented on the board of the Global Fund but are still significantly below their equitable contributions for this year. They are Austria, Canada, Japan and Switzerland.
The full Aidspan report is downloadable as a pdf at:
Portion of its Equitable Contribution that each of the 41 high-income countries has pledged for 2004 and 2005
(*Asterisks denote countries represented on the Global Fund’s board)
Portion of its Equitable Contribution 2004 & 2005
|Antigua & Barbuda||0%||0%||Finland||0%||0%||Liechtenstein||>100%||0%||Slovenia||0%||0%|
|Australia||40%||6%||France *||>100%||>100%||Luxembourg *||>100%||0%||Spain *||100%||33%|
|Austria *||0%||0%||Germany||100%||35%||Malta||0%||0%||Sweden *||>100%||0%|
|Barbados||0%||0%||Ireland *||>100%||0%||New Zealand||0%||0%||UK *||>100%||30%|
|Belgium *||>100%||0%||Israel||0%||0%||Norway *||>100%||0%||US *||>100%||18%|
|Canada *||51%||44%||Japan *||33%||0%||Qatar||0%||0%|
|Cyprus||0%||0%||Korea, South||2%||0%||San Marino||0%||0%|
Roche announces lower prices – MSF disagrees
Roche announced in June fresh price cuts for nelfinavir (Viracept) and saquinavir (Invirase) for developing countries. However the company was immediately contradicted by Médecins Sans Frontières, who said the company had made the announcement in Swiss Francs, but a translation into dollar prices showed price increases.
Roche said it was cutting the cost of a pack of 270 250-mg tablets of nelfinavir from CHF90.90 to CHF88.40, and a pack of paediatric nelfinavir powder from 49 CHF to 39.50. It said it was reducing the price of a pack of 270 saquinavir capsules from CHF 95.40 to CHF 89.60.
A company spokesman said Roche sells the drugs at no profit to sub-Saharan Africa and other poor countries and reviews its prices annually to ensure they still reflect the cost of production.
Sean Healey, the Information Officer for the MSF Campaign for Access to Essential Medicines, said in an email response: “In US dollar terms, the prices actually rise for nelfinavir 250mg tabs and saquinavir 200mg caps in sub-Saharan Africa and LDCs [least developed countries], and also for nelfinavir 250mg tabs, nelfinavir powder for suspension and saquinavir 200mg caps in low-income and lower-middle-income countries. Roche, who corporate HQ is in Switzerland, is virtually the only major drug company to still quote their prices in a currency other than US dollars.
Healey continued: “Nelfinavir and saquinavir are both important drugs, but unfortunately Roche still doesn’t take its responsibilities to patients seriously. In our view the Roche communication was in fact misleading.”
MSF calculates that the price of 270 tablets of nelfinavir has risen from US$65.61 to $69.76, that 270 200-mg capsules of saquinavir have risen from $68.57 to $70.71.
Source: Roche and MSF press announcements