As an amateur in the field of the global health, I have no special training or experience in the disciplines of the professionals- public health, epidemiology, microbiology, medicine, public policy- and so appreciate publications that synthesize the knowledge of experts into a digestible form. Hence my recent rereading of a 2010 report on vaccines by Paul Wilson of the Médecins Sans Frontières Campaign for Essential Medicines (MSF Campaign) was worthwhile (“Giving Developing Countries the Best Shot,” 2010 report). The report is a good accounting of the roles of the major players, including the biopharma industry, and is balanced; it doesn’t beat the drum for more for donor- and government-based solutions that the MSF, while clearly a force for good in the world, often advocates stridently.
The report starts with the good news that, in many of developing countries, immunization programs are in place and are preventing disability and death in millions of people for a good number of diseases: tuberculosis, polio, measles, diphtheria, tetanus, pertussis, Hepatitis B, Haemophilus influenza type b, rubella, mumps, and yellow fever. The less-than-good news is that the primary buyers of basic vaccines, the ministries of health of the low- and middle-income countries and the primary international financing authority, the Global Alliance for Vaccines and Immunization (GAVI), have been affected by the global economic depression and will not be able to meet the growing need. GAVI (Global Alliance for Vaccines and Immunization), is projected to be under-funded in the near term, in part due to declining donor income and in part to its commitments to purchase the newer pentavalent (diphtheria, tetanus, pertussis, hepatitis B, and Hib disease), pneumococcal, and rotaviral vaccines. The result is that GAVI will be supporting fewer purchases, and its goal of serving as a “pull” to encourage more companies to develop vaccines for global markets will be compromised.
For the biopharma industry, the good news is that, although public sector purchasing will be constrained, sales of vaccines in the low- and middle-income, “emerging” market, countries (LMIC) is projected to increase at 10% over the next five years (GEN article) and therefore will be an increasing part of the overall world market which is estimated as $34 billion in 2012. The report notes the major biopharma players (the multinational vaccine companies, GlaxoSmithKline [GSK] and Sanofi, and the new-comers, Merck, Novartis, and Pfizer) have a major challenge in creating pricing strategies that are both affordable to LMIC buyers and have returns-on-investment sufficient to support product innovation (and investor expectations). The current strategy is to have different prices in different countries (high in high-income countries to low in lower-income) and for large purchasers like GAVI and the Pan American Health Organization’s Revolving Fund which purchases vaccines for Central and South America. My reading of the report is that the healthy competition from LMIC vaccine companies and an increase in pricing information will drive the major companies to be more creative in both their pricing and their business development. In the latter category, the multinational vaccine companies may:
- partner with LMIC vaccine companies to gain local manufacturing capacity and regional market access (Sanofi’s $1 billion investment in India, FierceVaccines article);
- participate in the donor-supported vaccine product development programs to defray development costs of LMIC products (like GSK’s participation in the Malaria Vaccine Initiative, GSK press release);
- use corporate venture funds to buy into possible game-changing technologies specific to LMIC products (like adjuvants to stretch doses and products that do not require refrigeration), and
- participate in efforts to advance regulatory harmonization and strengthen national or regional regulatory authorities.
For other players, I read the report as a basis for more deal-making. The LMIC vaccine manufacturers may:
- build technical capacity, especially for multivalent vaccines and manufacturing, through sponsored/joint research with biotech companies, in addition to investing in internal R and D, and
- bid on public sector tenders to increase competition.
For the biotech companies, the advice is to:
- look for out licensing and collaboration opportunities with the LMIC companies; and
- join vaccine PDPs for visibility and possible funding.
For US universities and research institutions:
- use more open licensing policies and aggressive marketing to facilitate technology transfer to multiple innovators and suppliers especially in the LMIC; and
- work with other institutions to set up IP pools and technical advisory groups to enable licensing and technology transfer of vaccine-related technologies.
With the goal being lower costs for existing vaccines and new and better vaccines, the three-point shot is to increase competition, expand markets through public sector procurements and transparency, and innovate with better technology transfer and development.