Access to medicines—business as usual?

Lancet Global Health
Apr 2019  Volume 7Number 4e385-e532

Access to medicines—business as usual?
The Lancet Global Health
High medicine prices are never far from the headlines, affecting access for everyone from those living in the world’s most advanced economies to those in the least developed. The pharmaceutical industry, projected to be worth almost $1·6 trillion by 2020, is widely vilified for its role in this. Pharmaceutical companies are notoriously opaque in disclosing the exact costs involved in bringing a new medicine to the market. Industry-sponsored research suggests that the overall cost is around $2·6 billion.

Pressure is mounting on the industry. In February, seven global pharmaceutical company executives appeared before a Senate Finance Committee to answer questions on the high cost of prescription medicines in the United States. In 2016, the UN Secretary General’s High-Level Panel on Access to Medicines called on the sector to report on its actions to improve access and establish “direct board-level responsibility and accountability on improving access”. So, how has the industry responded?

The latest Access to Medicine Index, published last November, found that while all 20 pharmaceutical companies assessed have some form of access initiative in place, a small group of companies account for the most activity. The Index also identified company best practices, for example, programmes offering discounted prices or donating products. These initiatives are a step in the right direction but their actual impact on access is unclear.

In this month’s issue, Peter Rockers and colleagues report on the impact of one such initiative—Novartis Access, a new programme providing a portfolio of medicines for non-communicable diseases (NCDs) including cardiovascular diseases, type 2 diabetes, respiratory illnesses and breast cancer, at a wholesale price of $1 per treatment per month. Using a cluster-randomised controlled trial (RCT), the authors evaluated the effect of Novartis Access on the availability and price of NCD medicines in health facilities and homes in the first programme country, Kenya. After 15 months the authors found that the programme significantly increased the availability of amlodipine and metformin at health facilities but had no effect on the availability or price of the portfolio overall. They also found no impact on availability of the medicines at the household level.

Reducing the price of NCD medicines as part of an industry-led initiative did not translate into a change in access in Kenya, at least not during the first year. There are several possible reasons for this lack of uptake, including limited awareness of the programme, timing of regulatory approval and import, the medicines offered might not be the most sought-after treatments for NCDs, and the choice of distributor may have inadvertently excluded those who prefer to purchase their medicines from the private sector.

In an accompanying commentary, Imran Manji and Sonak Pastakia discuss how a wholesale price of $1 per treatment per month might not actually represent a discount, for example, hydrochlorothiazide, an alternative to amlodipine, typically costs less than $0·30 per month and might be preferred by both patients and providers. They note that “deriving impact from enhancing availability of medications is much more complicated than just having the products on shelves” and point to the need for collaboration with all levels of the health system. The World Health Organization (WHO) has addressed the multidimensional nature of improving access and the importance of a health systems approach in its draft Roadmap for Access 2019–2023, which outlines ten priority areas, including fair pricing, management of intellectual property, and procurement and supply chain management.

The findings might not be positive, but Rockers’ study is an important and overdue addition to the literature on industry-led efforts to improve access to medicines—an area that has been understudied so far. By scrutinising their access programme in an RCT, subjecting it to the rigours of peer review and publishing in an open-access journal, Novartis is setting the standard for how the industry should transparently report on its social programmes.

For now, it’s business as usual, but the debate over pricing and access is not showing any signs of abating. Last week, Italy’s Minister for Health, Giulia Grillo, proposed a draft resolution that aims to provide WHO “with an authoritative mandate to strengthen WHOs technical work on the transparency of the costs of research and development, and the transparency of prices.” We look forward to discussions of this proposal and further developments at the 72nd session of the World Health Assembly in May.