[Day 4] 28th Pan American Sanitary Conference: A binding research and development treaty to improve access to medicines – Feasible?

Day 4 at the 28th Pan American Sanitary Conference was welcomed by clear blue skies and sunshine as opposed to the clouds and day experienced the day prior.  Perhaps, this was a symbol of hope as PAHO moves into a new period with the election of the new Regional Director, Dr. Carissa Etienne yesterday. There is hope that the results of this meeting will not only be on paper, but will also become a reality in our region – the Americas.

During the morning plenary session, one of the more controversial resolutions that was tabled the day prior would be discussed amongst member states and civil society. At the World Health Assembly earlier in May, a report entitled Research and Development to Meet Health Needs in Developing Countries: Strengthening Global Financing and Coordination by the Consultative Expert Working Group (CEWG) on Research and Development. The report comes at a pivotal time when not only is the global economy unable to affordable the rising costs of medicines and treatments but also a time where there is a dearth of new medical products especially for those of neglected disease populations.

The report in its recommendations strives to align the incentives of industry in creating medical products for the purpose of profit with that of public health needs to allow for affordable access for patients. Additionally, the CEWG calls for member states to sign onto a binding treaty recommending a 0.01% of the GDP contribution towards a R&D fund. Many member states were adamantly against this proposal – most notably the first speaker, the United States stating that the first goal should not be asking for a dollar amount from countries in trying to overcome the R&D crisis, but rather focusing on implementing new models for innovation. Ironically, however, the United States did acknowledge that they contribute much more than 0.01% of their GDP towards R&D. Other countries voiced similar concerns including France as an observer state. There were a few countries however who voiced support for the recommendation of a binding treaty including Argentina, Colombia and Suriname.

Following member-states, Médecins Sans Frontières (MSF) and IFMSA as representatives from civil society were permitted to read their interventions. To read MSF’s statement, go here: ow.ly/dTnbF. Reshma Ramachandran of the IFMSA delegation read aloud IFMSA’s intervention as follows:

The International Federation of Medical Students’ Associations (IFMSA) welcomes the CEWG report on financing and coordination for R&D. Traditionally, the strengthening of intellectual property rights has been used as a primary method to spur innovation. This incentive, however, has not always proven fruitful especially for treatments not taken chronically such as vaccines and antibiotics – pharmaceutical classes that have seen a decline in R&D investment. In fact, in the Americas, case documentation has shown a rise in “superbugs” leading to patient deaths due to the lack of new antibiotics in the pipeline.

With such low investment in essential medicines due to failed R&D incentives, millions of our patients will continue to be neglected. Additionally, stricter intellectual property rights have led to the emergence of pharmaceutical monopolies and higher treatment costs, further burdening member states under economic strain. We, as future physicians, support the CEWG report in its mission to “align better commercial incentives and actions by the public sector with health needs, while also seeking to minimize costs.”

Representing over 1.3 million medical students worldwide, IFMSA respectfully urges member states to begin formal negotiations towards implementation of the CEWG report proposals. As healthcare providers, we wish to provide the best, most-evidence based treatments possible to our patients. This report provides a rare opportunity to merge the need for increased biomedical innovation with our professional responsibilities to our patients through coordinated public investment.

FIRST, public investments of innovative approaches to global health research such as those detailed in the report have led to great progress in overcoming current market failures. The CEWG proposals are already in place in the Americas. For example, the NIH National Center for Advancing Translation Sciences (NCATS) assists firms with their pre-clinical efforts in order to meet FDA requirements for investigational new drug applications so that drugs can reach first in-human clinical trials. Smaller companies and academic centers particularly benefit from this, garnering additional contributors to innovation. We therefore believe member-states should begin implementation of such successful models as outlined in CEWG report.

SECOND, many institutions and governments have already adopted Open Knowledge R&D mechanisms as recommended by the CEWG. In May of this year, Argentina passed a law making all government-funded research freely available in an online repository. NIH in the United States through its Public Access Policy ensures that NIH-funded research is available for free online within one year of publication. Such commitments to open access not only benefit patients and providers but also allows for the free flow of information to hasten innovation.

THIRD, several countries in the Americas are currently involved in secret negotiations for the Trans-Pacific Partnership (TPP) Agreement. Leaked TPP text includes provisions that will severely limit access to research and affordable medicines through extended data exclusivity and patent periods as well as low standards for patentability allowing essentially copies of older medications to receive patents. We are concerned that the CEWG proposals will be undermined by adoption of such TPP provisions especially in those member-states in the partnership.

FINALLY, we believe it is necessary that member-states adopt the CEWG’s recommendation regarding financing by contributing 0.01% of their GDP. Such commitment to R&D requires secure financing and this can only be achieved through funding commitments, not voluntary contributions.  One model mentioned earlier, the Global Fund, has in fact suffered from a lack of accountability from voluntary national contributors leading to the lack of funding of new proposals in 2011 and an uncertain future. We urge member-states to make such a commitment through a binding convention in order to ensure the success of such proposals detailed in the report.

We again ask member states to begin negotiations to implement the report’s recommendations as there is a dire need for novel, life saving treatments for our patients, especially those of neglected disease populations

The intervention was well received by member-states as well as those in PAHO who drafted the CEWG, sparking interesting discussion between IFMSA members and others about the real possibility of a binding treaty. From IFMSA’s point of view, without such a binding treaty, there will be no accountability or hope that the recommendations will be adopted by member states. In November, discussion will continue regarding the CEWG report and its implementation. IFMSA hopes to be present there as well to offer its support and suggestions along with the rest of civil society.

During the lunch break, the IFMSA delegation attended the Second Information Session on the Global Fund. The overall objective of this meeting was “Improved positioning of the region of Latin America and the Caribbean in the Global Fund’s governance and operational structures”. The meeting was geared towards:

  • Reviewing recent changes on the funding modalities for the Caribbean and Latin America region
  • Exploring possible collaborations to increase the ability of the member states and the region to best address issues relating to Malaria, AIDS and Tuberculosis.

What is the Global Fund?

Malaria, TB and AIDS affect many persons worldwide and not only are these diseases devastating, but more importantly, they are preventable. The Global Fund dedicates financial support to about 150 countries to aid in the prevention and treatment of these diseases. This is especially important within the Caribbean and Latin America region where there are many developing countries that without these resources would have found it impossible to tackle these maladies.

One area of policy change of the Global Fund is that countries will now be placed in bands based on the earnings of the countries. The focus of the Fund will then be directed on those countries that experience the highest disease burden and have the greatest difficulty in funding interventions. It is purported that this change will ensure that there will be decreased morbidity and mortality from these diseases. The member states however questioned the use of the World Bank’s Income Classification in determining the economical status of each country. This classification uses the gross national income (GNI) per capita. It does not take into consideration debt or spending requirements of the countries.

Some countries within this region, however, thought this would present more harm than good for their nations. Jamaica, for example was listed as one of the countries that would have a cut in the funds that would normally be received. The Minister of Health, however, pointed out that as it relates to AIDS, this would have negative impacts for the island as the Ministry would now have great difficulty in funding wages for persons who were trained and now employed by the Ministry to head prevention and information campaigns in the move to eradicate HIV/AIDS.  The Minister suggested that when changes are to be made in funding policies, more time should be given to enable countries to better transition so that their achievements may be maintained or improved. Another issue with the changes was whether it would be taken into consideration those countries that have formed economical collaborations because they are unable to face to global market individually.

The meeting also reviewed the targets of the region for 2012-2013:

  • Promote treatment optimization in at least 5-7 countries
  • Accelerate Mother to Child transmission in at least 3-5 countries

Reshma Ramachandran (AMSA-USA) and Sachalee Campbell (JAMSA)

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