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. 2016 Jun;18(1):25–41.

Table 1.

The right to enjoy the benefits of scientific progress: Actors, duties and responsibilities related to Multidrug-Resistant TB (MDR-TB).

Actor*
Domain of activity Domestic state Home state of pharma company Private pharma University and research institutions Global foundations and consortia
An intellectual property system that enables the REBSP
  • Establish an IP system that rewards R&D but does not place obstacles to the REBSP for neglected diseases

  • Duty to respect

  • Desist from using IP provisions when domestic state has thoughtfully and appropriately sought alternative routes.

  • Duty to respect

  • Engage actively in translating CSR commitment into rights responsibilities for IP issues

  • Lobby for an IP system that rewards R&D but does not place obstacles to the REBSP for neglected diseases

  • Actively promote an IP system that rewards R&D but does not place obstacles to the REBSP for neglected diseases

Basic science to identify new drugs and trials to establish efficacy and effectiveness
  • An overarching science policy reflecting the REBSP

  • Duty to facilitate

  • Strengthen research capacity in LMICs through technology and knowledge transfer without IP hindrances.

  • Duty to facilitate

  • Respond to responsibilities outlined in Guidelines for Transnational Corporations by pursuing relevant research

  • Conducting research relevant to MDR-TB

  • nIcrease public accountability for decision making as to what is funded and how

  • Direct state funding for research on MDR-TB

  • Duty to provide

  • Subsidies or tax advantages to encourage private sector

  • Duty to fulfill

  • Desist from ever-greening practices that remove potentially effective drugs from a development pipeline

  • University to develop and implement systems to support responsive research

  • Contribute to funding for R&D on new medicines

  • State adherence to commitments for funding R&D

  • Duty to provide

  • Investment in human resource capacity to do research

  • Duty to facilitate

  • Translate responsibilities through technology transfer to LMICs

  • Capacity development of researchers to deliver research outputs needed.

  • Engage with (donor) states, NGOs, and international organizations to promote and organize R&D on new medicines

  • Subsidies or tax advantages to encourage private sector

  • Duty to facilitate

  • Allocate university resources to promote relevant research

  • Soliciting partnership agreements to support research

  • Duty to facilitate

  • Regulatory action to ring-fence public sources (such as tax)

  • Duty to facilitate

Basic science to identify new drugs and trials to establish efficacy and effectiveness
  • Investment in human resource capacity to do research

  • Duty to facilitate

  • Expedited regulatory approval for trials

  • Duty to protect

Developing regimens for existing repurposed drugs#
  • Expedited regulatory approval for appropriate indication

  • Duty to facilitate

  • Ensuring sufficient pharma capacity for drug manufacture

  • Ensuring sufficient pharma capacity for drug manufacture

  • Exploratory research to identify candidate drugs for repurposing

  • Mobilizing resources globally for development and operational research

  • Negotiations on cost with pharma (tender agreements, with forecasting)

  • Duty to facilitate

  • Ensure rights to a drug are available (give away rights) if pharma has no interest in manufacture

  • Setting up global consortia for purchasing

Regulatory approval post trials
  • Fast-track or expedited processes for neglected diseases

  • Duty to facilitate

  • Pursue registration of drugs vigorously following successful demonstration of effectiveness

  • Providing expertise for advice in regulatory decision-making

Regimen development
  • Permitting operational studies; flexibility in registering drugs in post-RCT phase

  • Duty to facilitate

  • Engage with government regulatory authorities

Operational implementation
  • Training of staff

  • Duty to promote

  • Desist from imposing forms of patent protection on LMICs that inhibit access to essential medicines

  • Duty to respect

  • Desist from lobbying home country governments for excessive patent protection

  • Active research dissemination; university commitment of resources for dissemination

  • Development of treatment protocols for up-scaled implementation

  • Duty to facilitate

  • Contribute to funding through donor and multi-stakeholder structures

  • Duty to provide

  • Contribute to funding through donor and multi-stakeholder structures for accelerated drug-development for DR-TB

  • Training of staff in research dissemination

  • Support operational research

  • Duty to facilitate

  • Contribute to mobilizing multi-stakeholder partnerships to support implementation

  • Duty to facilitate

  • Public education on TB science to strengthen civil society voice

  • Public education on TB science

  • Duty to promote

  • Abstain from activities that delay, postpone, or block availability of new drugs

  • Duty to respect

  • Prioritize concrete and targeted measures aimed at reaching vulnerable members of society

  • Duty to facilitate

*

Additional actors may include the World Health Organization, whose stewardship role obliges it to facilitate and coordinate cooperation for DR-TB drug development, and civil society, whose roles include holding state and other actors accountable, including bringing cases to court where appropriate, promoting public information and awareness, and mobilizing community voice.

#

The obligations and responsibilities with regard to developing regimens for existing repurposed drugs largely include those that pertain to different actors with regard to basic science identification of new drugs and establishing their efficacy and effectiveness, and are not repeated in this row—only matters that are specific for access to existing drugs.