Fair Pharma Richtlijnen

Farmaceutische bedrijven hebben volgens het Mensenrecht op Gezondheid de verantwoordelijkheidom te zorgen dat hun geneesmidelen beschikbaar, toegankelijk en betaalbaar zijn.

Maar hoe ziet dat er in de praktijk uit?

Hier staan een set (internationale) richtlijnen uitgewerkt die farmaceutische bedrijven kunnen volgen om verantwoord te ondernemen in lijn met mensenrechtenprincipes. Idealiter krijgen deze richtlijnen juridische bindende waarde.

Vaccine and therapeutics companies should...

  1. Publicly commit to adhering to the United Nations Guiding Principles on Business and Human Rights and to the Human rights responsibilities for pharmaceutical companies in relation to access to medicines
  2. Devise and publish a human rights strategy for their product. This should include a plan for equitable global distribution of Covid-19 medical products and conducting regular human rights impact assessmentsto identify the adverse effects of the business plan.
  1. The company commits to an international responsible licensing mechanism, such as the WHOCovid-19 Technology Access Pool (C-TAP) or the Medicines Patent Pool, and discloses which information it has shared, or is intending to share, with such a mechanism, as the MPP full disclosure policy dictates.
  2. The company commits to not enforcing intellectual property rights related to Covid-19 products. Patents are meant to stimulate innovation and research into life-saving products. However, they also give the patent-holder market exclusivity, meaning that the patent-holder can set the price as high as it likes. Because of this monopoly, the product often becomes excessively expensive. Patents and other exclusive rights also have a huge impact on global production capacity, which is especially important regarding shortages for Covid-19 vaccines. Companies can avoid these issues by licensing the product for use in LMICs (through C-TAP or MPP), or by developing a differential pricing strategy that ensures fair pricing for all.
  3. The company signs agreements to supply the vaccines/therapeutics pillar of the ACT Accelerator (COVAX) with their products. Vaccine ‘hoarding’ by high-income countries has so far severely limited COVAX’s ability to buy enough doses to distribute to lower-income countries. Companies can limit this by prioritising purchase agreements with COVAX rather than with high-income countries.
  1. Therapeutics companies make the active pharmaceutical ingredient (API) for their product available at a ‘fair’ price and on reasonable grounds.
  2. Vaccines and therapeutics companies commit to full technology transfer to other manufacturers. This involves many channels, including the transfer of physical equipment, providing training for researchers, and licensing the technical, organizational and procedural knowledge required to manufacture the product. So far, the companies that have shared technology have done so in a restrictive way, resulting in ‘fill-and-finish’ sites instead of a full production process. [1]
  3. Companies commit to non-profit pricing, at best, or ‘fair’ pricing, at the least. For any medical product, this means a price that is ‘affordable to the buyer while covering the seller’s costs and providing a reasonable profit margin’. A fair price will also differentiate between low-income and high-income countries. There is no ‘set’ threshold of fairness, as many factors determine the price of a product, including R&D expenditures and efficacy. Transparency in a company’s purchasing agreements is therefore also key to determining and achieving a fair pricing strategy.
  4. Vaccine companies commit to equitably distributing their supplies around the world. This could involve setting up an internal quota system within the company, which would allocate a certain number of doses to low- and middle- income countries, and prevent high-income countries from stockpiling supply.
  5. The company agrees to waive exclusive rights in regulatory test data where applicable.
[1] Eg Novavax with the Serum Institute in India. See here for a comprehensive overviewof why technology transfer is necessary.  
  1. The company publishes its R&D costs, profit margin, and average costs of production. This information should be easily available in the public domain because it is vital for the public to assess the prices set. It should also be available per product. This data is also necessary to verify any claims made by the company – for example, a commitment to non-profit pricing should be backed up by quarterly financial reports and information on the costs of production.
  2. The company publishes its production capacity. This is crucial for transparency in the supply chain and, in the context of a global pandemic, to accurately predict how many doses will become available.
  3. The company publishes the amount of public subsidies it received during product development and/or testing. This greatly influences the amount of leverage governments have for making companies adjust their prices, for example. [2]
  4. The company publishes the text of licensing agreements. This allows for scrutiny of the deals made with manufacturing companies. Given that many vaccines are publicly funded, this is information that the public has a right to know. Ideally, a ‘good’ license should contain provisions on global access and generics to drive down prices and increase access, and remove any additional barriers to access such as patents or data exclusivity.

    [2] The UAEMframework on Global Access Licensing is a useful guide.