With the coronavirus pandemic set to continue without an effective and widely-available vaccine, all eyes are on the pharmaceutical sector. In recent years the industry has been scrutinised for unethical selling practices and raising drug prices, yet the pandemic presents an opportunity for the sector to re-establish its value to society. In this article we will look at its response to the pandemic and how we are engaging with companies to ensure fair and equitable access to treatments and vaccines.
It has been encouraging to see the pharmaceutical and healthcare sector leap into action through the development of treatments and vaccines for Covid-19. By mid-May there were over 150 treatments being tested in over 1,000 clinical trials. According to the World Health Organization there are currently over 180 possible vaccine candidates, with 35 in human clinical trials. Typically, vaccines have a 93% failure rate from the lab to licensure, according to the International Vaccine Institute. Therefore, even with fast-tracked regulatory approval, it is expected that the pipeline could yield around seven products over the next few years, based on historical attrition rates.
Despite this race to develop vaccines, treatments and diagnostics, we remain concerned about the lack of commitment and action across the industry to act ethically and responsibly to ensure safety and efficacy, as well as fair and equitable access. We have seen Covid-19 seamlessly cross borders, so without treating and preventing outbreaks globally, or completely shutting our borders, the virus will re-emerge. Therefore, we are engaging with pharmaceutical companies to ensure they consider a global access approach.
We have been particularly concerned about early actors setting a precedent by limiting the initial supply of treatments within certain country borders. We will need to ensure that companies consider new and innovative mechanisms to assess country-specific needs and equal distribution, whilst preventing stockpiling. Companies and health authorities will also need to rapidly expand manufacturing whilst ensuring product quality and safety, and consider innovative methods such as patent sharing.
Gilead Sciences had to backtrack after it secured “orphan drug” status for its remdesivir anti-viral drug, seen as a promising potential treatment for Covid-19. We pushed the company to improve its response, seeking greater clarity on how it would produce a drug at low or no margin. We also encouraged it to provide a global response, not just focus on the US.
We have seen from engagement that the most successful models for addressing global health challenges involve multi-stakeholder partnerships. These should include pricing flexibility from pharmaceutical companies, investment in health spending from countries, guidance and coordination from bi- and multilateral organisations, and education about vaccination programmes and distribution, with assistance from NGOs.
With weaker purchasing power and more fragile healthcare systems, the pandemic will undoubtedly devastate lower- and middle-income countries far more than developed markets. Companies should consider both differential pricing between countries (inter country pricing), as well as within (intra country pricing), depending on the country and an individual's ability to pay. Yet there is no silver bullet, as even tiered pricing approaches upset nations that may narrowly miss out on a lower tier price. They can also create new challenges, such as the risk of product diversion.
The challenge moving forward, and on which we will continue to engage, is ensuring that the current momentum around access to vaccines for infectious diseases continues. According to the Access to Medicine Index, in 2018, R&D for emerging infectious diseases comprised just 1% of total R&D projects. In addition, whilst there are about 240 vaccines in the early stages of development to treat diseases predominantly affecting people in developed counties, only a small number of vaccines have made it through the pipeline in recent years for use in low-income countries.
Public funding to kick-start Covid-19 vaccine development has been significant. To incentivise further vaccine development for infectious diseases, we need to engage with companies and policymakers to create sustainable incentive models that decouple product pricing from R&D costs. This can be achieved through mechanisms such as push funding or grants, or similar incentive models to those we discussed in our previous article on antibiotics R&D. Covid-19 has demonstrated why this is a material issue for the long-term sustainability of the sector, otherwise, without a more sustainable vaccine pipeline, we may be entering an era of pandemics.