WHO Fair Pricing Forum Focuses on Biosimilar Access in Middle- and Low-Income Countries

In Johannesburg, South Africa, the World Health Organization (WHO) recently arranged for closed meetings between government representatives, nongovernmental organizations, academics, experts, and the pharmaceutical industry to address concerns regarding fair pricing and patient access to pharmaceuticals, particularly related to middle- and low-income countries. The second Fair Pricing Forum took place from April 11-13, 2019.

At the first meeting in Amsterdam 2 years ago, several issues related to innovative and generic drugs were discussed. This year’s meeting was intended to further discuss these issues and to assess progress made. In this article, I will give a brief general overview of the main drug-pricing—related issues discussed with an emphasis on biosimilars.

Policies on Biosimilars

In the first meeting, there was no specific focus on biosimilars, but the following relevant comments were included in the report regarding availability of generic medicines: “There is an urgent requirement for collaboration between authorities to establish an inventory of needs and to develop policy options to address these (availability of generics) needs. The establishment of a structured discussion between competent regulatory authorities, payers, and industry to identify which molecules are needed, at what price, and how to ensure the future stability of the market was suggested. The need to set rules for tendering, taking into account not just price, but also liability, quality and sustainability was highlighted. The value of pooled procurement in order to achieve adequate volumes was also emphasized.”

This year, a session specifically devoted to discussing experience with biosimilars focused on biosimilar policies, supply- and demand-side barriers, and opportunities to address these issues.

The underlying concern among the group has been the generally slow adoption of biosimilars, and discussions with more than 200 country representatives yielded the following issues and causes of delayed uptake:

Education of physicians, medical staff, patients, and payers

Country participants confirmed ongoing problems with awareness and knowledge of biosimilars with physicians, nurses, patients, and payers. In oncology, a need for more information about the impact of switching on immunogenicity and the extrapolation of indications were noted. Physician hesitance to prescribe biosimilars was recognized as a hurdle in many countries.

Guidelines on interchangeability

Specific guidelines on interchangeability were noted by many as lacking, and were pointed to as an added reason for hesitance among physicians to prescribe biosimilars, particularly as most countries did not have specific incentives in place to encourage biosimilar prescribing.

Efficient regulatory process for biosimilars

Backlogs in the registration of biosimilars was noted as a significant issue in many countries. Registration delays in South Africa, for example, have significantly impacted the availability of biosimilars; however, many countries have noted similar issues. A clear regulatory process for biosimilars is often lacking.

Pricing policies

Many countries do not have clear pricing regulations for biosimilars or incentives to prescribe biosimilars.

Tender strategies and keeping a healthy balance between competition and sustainability

Some countries felt a need to be able to institute tenders by specific indication to gain more leverage with drug makers. However, there was also a general consensus that overly competitive tender policies can lead to drop-out of suppliers and eventually supply challenges and excessive price increases as we have seen for generics.

Different from the fair pricing discussions for patented drugs, the discussion related to biosimilars was more collaborative. Obviously, biosimilar products can be a part of the solution to improve affordability and access to drug treatments for patients. Issues related to slow uptake of biosimilars in low- and middle-income countries are similar to those in the United States and Europe, but each country requires a local approach.

Fair Pricing and Patient Access

As can be expected, the topic of drug pricing in relation to patient affordability in middle- and low-income countries is a complex one, riddled with a mix of social and economic issues that lead to emotional and often polarized discussions.

Although the meeting was polarized at times, and under accompaniment of protesters outside, sitting around the table led to some opportunities to find common ground. While many activist groups seek a single solution in terms of forcing widespread compulsory licensing for particularly anticancer drugs, discussions during the forum focused on a stated need for transparency in price and research-and-development (R&D)—related costs. While it is highly questionable whether transparency in R&D cost will lead to any price reductions, the economics of drug discovery and development are clearly in need of better explanations than the ones provided so far.

Stakeholders agreed that differential pricing opportunities, which allow for lower prices in countries with lower income levels, need further exploration; however, this possibility is critically dependent on the restraint of higher-income countries to reference prices of relatively lower-income countries. Recent examples of the US International Price Index and the Canadian reform of its Patented Medicines Prices Review Board pricing basket illustrate the problem.

More about fair pricing discussions and implications for products with an existing patent can be found at www.thepriceofglobalhealth.com.