Improving Global Access to New Vaccines: Intellectual Property, Technology Transfer, and Regulatory Pathways

摘要

The 2012 World Health Assembly Global Vaccine Action Plan called for global access to new vaccines within 5 years of licensure. Current approaches have proven insufficient to achieve sustainable vaccine pricing within such a timeline. Paralleling the successful strategy of generic competition to bring down drug prices, a clear consensus is emerging that market entry of multiple suppliers is a critical factor in expeditiously bringing down prices of new vaccines. In this context, key target objectives for improving access to new vaccines include overcoming intellectual property obstacles, streamlining regulatory pathways for biosimilar vaccines, and reducing market entry timelines for developing-country vaccine manufacturers by transfer of technology and know-how. I propose an intellectual property, technology, and know-how bank as a new approach to facilitate widespread access to new vaccines in low- and middle-income countries by efficient transfer of patented vaccine technologies to multiple developing-country vaccine manufacturers. Vaccine rollout in low- and middle-income countries (LMICs) routinely lags far behind rollout in high-income countries. As of 2010—a full decade after its introduction—87% of high-income countries included the pneumococcal conjugate vaccine in their immunization schedules, compared with only 2% of low-income countries. 1 Although the Haemophilus influenzae type b (Hib) vaccine was being widely used in wealthy countries by the early 1990s, Hib vaccine coverage in Africa was estimated at 24% as of 2006. 2 Twenty years after licensure of the hepatitis B vaccine, vaccine coverage was estimated at 90% in the Americas as opposed to only 28% in Southeast Asia, where hepatitis B is endemic. 1 These timelines, unfortunately, are the norm rather than the exception for adoption of new vaccines in LMICs. The inequities of this situation are all the more indefensible because the vast majority of mortality from vaccine-preventable diseases occurs in LMICs 3 ; it is estimated that more than 90% of deaths from pneumococcal disease, 4 95% of deaths from Hib, 5 and 80% of deaths from hepatitis B 5 occur in developing countries. In May 2012, the 65th World Health Assembly endorsed the Global Vaccine Action Plan (GVAP), 6 a document that sets ambitious vaccination goals for the upcoming decade. The GVAP reflects the growing recognition by governments, international agencies, and civil society of the importance of vaccines not only for achieving international health priorities but for addressing global issues such as poverty, hunger, education, and gender equality. 7 One of the key objectives outlined by the GVAP is for all immunization programs to have sustainable access to universally recommended vaccine technologies within 5 years of licensure. There is an enormous gap between this goal and the current reality of new vaccine rollout in LMICs, and the GVAP recognizes that innovative mechanisms will be needed to support scale-up of new vaccines within the proposed timeline. The Decade of Vaccines collaborative that created the GVAP has proposed the goal of achieving universal vaccine access by 2020 8 ; it is estimated that this goal will cost more than US $57 billion, with new vaccines responsible for over half the cost. 9 Although there are numerous social and logistical obstacles to the adoption of new vaccines in LMICs, a clear consensus has emerged that one of the greatest barriers is vaccine pricing. 10–15 This problem is being compounded by the increasingly high costs associated with recent vaccine innovations. The newly developed human papillomavirus (HPV) vaccine, for example, is the most expensive vaccine in history 16 ; this is particularly problematic because the overwhelming majority of cervical cancer cases occur in developing countries. 17 Like many new vaccines, the high cost of the HPV vaccine will be most prohibitive in exactly the places it is most needed, and it is unlikely that expensive new vaccines such as the HPV vaccine will become widely accessible in LMICs without extensive external funding. Currently, the most important source of external funding for vaccines in low-income countries is the Global Alliance for Vaccines and Immunizations (GAVI). GAVI’s critical role in the introduction of new vaccines to low-income countries, most recently with its commitment to introducing the HPV vaccine, 18 cannot be overstated; however, there are significant limitations inherent in this support. First, new vaccine introduction is only 1 component of GAVI’s vaccination programs, and the decision to introduce a new vaccine is based on numerous factors, which inevitably include the price of the vaccine and GAVI’s current financial status. In 2010, GAVI was facing a serious budget shortfall of over $4 billion, which threatened to limit future plans to introduce new vaccines. 19 GAVI was able to raise sufficient funds to overcome this budgetary crisis; however, the shortfall highlights co