Information and Examples

«


About UAEM


Universities Allied for Essential Medicines (UAEM) is an international network of students and researchers who believe that biomedical research and development (R&D) should be health needs-driven and that access to medicines should be a reality for all. Most of us have pursued degrees and professions in biomedical R&D and other health-related fields hoping to improve people’s quality of life. However, the way in which R&D is regulated and executed is becoming increasingly based on seeking profits rather than treating patients. The current system often obstructs collaboration and efficiency in drug development, and results in serious inequities in both research priorities and access to medicines. After years of discussions, there has been work done by United Nations agencies and expert committees, including the World Health Organisation Consultative Expert Working Group on R&D, as well as civil society and academia, to build consensus concerning the key principles and practices needed to achieve a more just and equitable approach to biomedical R&D. While some initiatives currently abide by these principles, few steps have been taken to introduce and adopt them more broadly at the national or international levels. Through this Charter, we seek to build on this previous work to define and build consensus concerning principles and practices that can better enable ethical R&D worldwide, and ensure that resulting technologies and medicines meet global health needs.



R&D Principles & Practices Explained


R&D has to be evidence-based
This includes:
  • Generating and sharing R&D outcomes as public goods, freely available for further research and production. All research results, negative and positive, need to be published, including results from all clinical trials.
  • Promoting genuine innovation by encouraging the use of definitions of invention and patentability that minimise evergreening and maximise novelty.
  • In rewarding new inventions (through granting a license, a prize or other forms of reward), requiring that new treatments show therapeutic benefit over existing ones. The efficacy of a new treatment against the best available treatment (and not just against a placebo) should be displayed., through comparative effectiveness research.
  • Trial design and analysis should be guided by evidence to prevent exaggeration of benefits and underreporting of harms.
  • Marketing should not influence doctors’ drug prescribing practices, doctors’ decisions need to be made only on the grounds of evidence. Thus, marketing to doctors should not be legally permitted


R&D has to be guided by principles of openness, transparency and effectiveness
This includes:
  • Generating and sharing R&D outcomes as public goods, freely available for further research and production. All research results, negative and positive, need to be published, including results from all clinical trials.
  • Promoting genuine innovation by encouraging the use of definitions of invention and patentability that minimise evergreening and maximise novelty.
  • In rewarding new inventions (through granting a license, a prize or other forms of reward), requiring that new treatments show therapeutic benefit over existing ones. The efficacy of a new treatment against the best available treatment (and not just against a placebo) should be displayed., through comparative effectiveness research.
  • Trial design and analysis should be guided by evidence to prevent exaggeration of benefits and underreporting of harms.
  • Marketing should not influence doctors’ drug prescribing practices, doctors’ decisions need to be made only on the grounds of evidence. Thus, marketing to doctors should not be legally permitted.


R&D has to be guided by principles of efficacy and efficiency
This can be achieved through:
  • Open approaches
    • Fostering collaboration over competition, under the principle that research results and data should be in the public domain. Research institutions that receive public funding should adopt policies and approaches that catalyse innovation and create flexible models of collaboration that advance biomedical research and generate knowledge for the benefit of the public.
    • Promoting Open knowledge innovation: research and innovation that generate knowledge which is free to use without legal or contractual restrictions. Such open approaches to R&D include pre competitive R&D platforms, open source and open access schemes.
    • Open approaches should also be embedded in the design of milestone and end stone prizes to reward innovation.
  • Transparency
    • There should be no limitations to data sharing. Clinical trial data and protocols should be publicly shared within 12 months of the trial’s completion. All clinical study reports ever conducted should be made available.
    • Transparency in the cost of R&D should be sought, by disclosure of costs associated with R&D for any given drug (factoring in tax incentives and public investments).
    • The price of medicines (including potential rebates and discounts) purchased by public health systems should be made publically available.
    • Gagging clauses that allow sponsoring companies to gag publication should be stated clearly. This means patients participating in trials with gagging clauses should be informed about them upfront. Academic papers, trial protocols and trial registry entries should state them clearly as well.
    • In funding of later stages of R&D, giving priority to molecules offering significant benefit over existing treatments, or offering treatments for conditions that currently have precarious or no treatment.


And by the principles of affordability and equity
  • Acting on the need for innovation in research areas affecting populations where health needs are currently neglected. Equitable licensing options would promote building research capacity in academic and public research organizations in developing countries by the transfer of technology to them.
  • Promoting global access through affordable pricing of medicines and medical technologies. Managing intellectual property in a manner that maximizes health-related innovation and protects public health. Patient's access should be prioritised over high prices or profits.
  • Public funding should be attached to conditionalities which safeguard public interests. These conditions should ensure affordability of the any downstream products, patient access to these products and ownership of the innovation itself. The outcomes of all publicly-funded research must be affordable to all those in need - the outcomes of R&D should be always considered public/social goods.
  • Moving towards an R&D model where an exclusive license to produce a medicine is not the main reward for R&D, but non-monopoly based incentives that ensure access and affordability prevail. Whilst moving towards such a model, current patents should be added to public sector patent pools.
  • Making full use of the provisions of the current R&D paradigm to effectively overcome current barriers to access. The ability to use non-exclusive licenses to produce generic versions of drugs in places where currently patented drugs are too expensive is necessary. This can be achieved through the granting of voluntary licenses by current patent holders in all affected countries with the capacity to produce the medicine. It can also be achieved through governments issuing compulsory licenses, in which case it is necessary for countries to be able to make full use of TRIPS flexibilities free from politico-economical barriers beyond law such as undue political and commercial pressures.


R&D costs and medicines’ prices need to be delinked
  • It is a common argument that high drug prices are caused by expenses for and investments in R&D. By awarding innovative research with milestone prices instead of decades-long patents we can de-link R&D costs from pricing. This will lead to generic competition and setting of drug prices closer to the actual production costs.
  • Delinking the price of medicines from the cost of R&D is key to overcome both the innovation and the access gaps. Proposals such as Advanced market commitments or the Priority Review Voucher would not achieve delinkage.


R&D has to be a global shared responsibility
  • For such an R&D paradigm to become a reality, a new framework for R&D needs to be collectively created embedding these principles in R&D policies and practices. Such an R&D framework should be supported by a priority-setting and coordination mechanism, and by sustainable funding for R&D.
  • Sustainable financing is required to ensure R&D’s independence from revenue expectations. Nonetheless, lots of money is already invested in R&D worldwide although not always having the health impact we hope, thus it is important that this wealth is directed where it is needed and that outcomes reach patients. All the above principles should be requirements for the granting of public money.
  • All countries should commit to spend at least 0.01% of GDP on R&D towards health needs in developing countries. Part of this funding (20% - 50%) should contribute to a global pooled fund via mandatory contributions, coordinated by the WHO and ensuring financing of R&D according to health needs. Such a fund should be part of the broader R&D Agreement or Convention, signed by all WHO Member States, and should follow the principles stated above.


These guiding principles for R&D should be applied at both the global and the national level through a WHO R&D Agreement or Convention that countries can ratify nationally. For an agreement to be successful it must be binding for Member States.

Note: These principles and the notion of an R&D Agreement or Convention were proposed by the WHO Consultative Expert Working Group on Research and Development (CEWG) and are further supported by the recent report by the UN High Level Panel on Access to Medicines (UNHLP). Much of the language describing specific practices that would enable these principles to be attained is also adopted word by word from the CEWG and the UNHLP reports. WHO Member States already agreed that R&D should abide by these principles (in Paragraph 6 of the WHA69/B/CONF./6 paper) at the 69th World Health Assembly. However, after years of discussions, no steps have been taken by the WHO or its Member States to ensure this is implemented through a legally-binding R&D Agreement or Convention. Whereas trade agreements are popular, conventions or agreements in relation to health are scarce: the Framework Convention for Tobacco Control is the only such example. The World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is the only current global agreement regulating R&D, and it does so from a trade perspective rather than from a health perspective.



Examples of Principles & Practices in Action
UAEM’s charter aims to build consensus among governments and research institutions on the principles and practices necessary to achieve a more just and equitable approach to R&D. Outlined here are existing alternative R&D initiatives and institutes which adhere to or implement one or more of the aforementioned principles and practices. These examples, sourced from UAEM’s mapping of the alternative biomedical R&D landscape, serve to underline both the feasibility of and an avenue for implementation for each of the principles and practices outlined above. They are not a comprehensive list of existing initiatives but provide an overview of how this charter relates to and promotes a process for R&D that can and already is working to ensure better access to medicines.

To further explore initiatives applying these principles in practice, go to altreroute.com and click Explore the Data.

Together, these principles and practices can be thought of as rules, which comprise a set of best practices to achieve the ultimate goal of access to novel, safe, effective, affordable and accessible medicines. To maximise the public health impact of biomedical R&D, states should take the following steps to ensure R&D aligns with the above rules:
  • Conduct a review of existing R&D initiatives and evaluate those based on their ability to deliver medicines in concordance with the rules;
  • Conduct feasibility studies for the implementation of proposed R&D mechanisms and initiatives that abide by the rules;
  • Educate policy makers of the potential benefits of alternative approaches to R&D ;
  • Embed these principles in their national R&D strategies and in international agreements affecting R&D and access to medicines. This includes but is not limited to policies which make the granting of public money to research institutions (eg. universities) conditional upon compliance with these rules;
  • Create new, non-IP based, rewards incentivising R&D which align with these rules;
Universities, public research institutions and ultimately, governments have the responsibility and opportunity to take leadership and leverage the power they have to shape the biomedical R&D landscape in favour of the public interest.

CONTACT

North America:  info@essentialmedicine.org
Europe:     office@essentialmedicine.org
Brazil:     freemeds.sara@uaem-br.org

To learn more about UAEM or to donate visit www.uaem.org