The Next Frontier for Public Health Medicines Market

1. The Next Frontier for Public Health Medicines Market Rethinking priorities for improved access to quality-assured medicines for Universal Access Kwasi Poku Boateng Director, United States Pharmacopoeia-Ghana

2. Outline • Public Health Medicines Market • Current Situation • Next Frontier • Needed Initiatives and Interventions • Bangladesh case study

3. Current Situation • Public Health Medicines Market 2 billion people still lack access to essential medical products mostly in low- and middle-income (LMIC) countries LMICs are also confronted with the following: • Communicable diseases are major public health burden • Evolving challenges like antimicrobial resistance (AMR) and noncommunicable • Funding for procurement of public health medicines mainly from donors • Funding disproportionately favors communicable diseases • Medicines shortages and stock-outs are commonplace, in many cases the manufacture of these medicines is being consolidated to fewer and fewer pharmaceutical companies.

4. Current Situation • Public Health Medicines Market • Fragmented and opaque procurement and distribution processes that are prone to corruption, pilferage, and product degradation. • A lack of effective regulatory capacity impeding availability of medicines in many LMICs • Proliferation of Substandard and Falsified Medicines, WHO estimates 10.5% of medicines available in LMICs. • More than 70% of medicines used in Africa are imported. This % is higher for vaccines, injectables and other advanced dosage forms.

5. Next Frontier • Public Health Medicines Market LMICswith a high population growth rate e.g. Africa, with an estimated annual growth rate of2.6% is poised to become a major market for public health medicines Double burden of diseases, characterized by the increasing prevalence of chronic non-communicable diseases (NCDs) while communicable diseases still remain a problem The Essential medicines portfolio will include: • An increasing number of therapies for NCDs • New classes of antimicrobials because of AMR • Increasing number of biologic and biotechnology products The capacity to effectively regulate these medicines will be a challenge

6. Next Frontier • Public Health Medicines Market The medicines bill will increase, but donor funding for procurement of public health medicines will decline Global pharmaceutical markets will become less able to respond to the needs of LMICs. New technologies will enhance the ease to falsify medicines as well as providing alternate unauthorized distribution channels Increasing recognition of the importance of developing local pharmaceutical production.

7. Expanding access to quality-assured medicines Needed Initiatives and Interventions Despite infrastructural, policy, and human resource capacity challenges analyses and practical experience suggest that competitive pharmaceutical production in LMICs is both feasible and economically viable. Global development efforts to increase access to medicines should be accompanied by greater investment and targeted efforts to ensure that regions like sub-Saharan Africa are able to develop the capacity to produce, regulate, and procure priority essential medicines. This capacity is especially important for middle-income countries that are graduating from development assistance.

8. Expanding access to quality-assured medicines Needed Initiatives and Interventions Potential benefits of Local pharmaceutical production (LPP) • Proximity to market of local pharmaceutical production confers several possible benefits in terms of increasing access to medicines. Local manufacturers are better positioned and motivated to respond to local needs. • LPP fills an important market gap for essential medicines that may have relatively low profit margins and are less attractive for larger foreign companies to produce. • There is some evidence that the emerging industry can help drive improvements in both manufacturing and regulatory capacity. • When LPP leverages knowledge and technology transfer opportunities, significant benefits have been documented in terms of “spillover” knowledge.

9. Expanding access to quality-assured medicines Needed Initiatives and Interventions Momentum for investing in and supporting local production of medicines has been growing. • In 2008, the WHA adopted the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property. • Following the adoption of this resolution, WHO and its partners, with support from the European Commission, launched a Local Manufacturing Initiative to increase access to essential medicines, vaccines, medical devices, in vitro diagnostics, and blood products. • The Pharmaceutical Manufacturing Plan for Africa (PMPA) and the associated Business Plan for the PMPA, developed by the AU Commission with support from UNIDO, helped to lay the groundwork for this type of large-scale investment to grow the pharmaceutical industry on the continent. • At the country level, for e.g. in 2015, Ethiopia launched the National Strategy and Plan of Action for Pharmaceutical Manufacturing Development in Ethiopia. • Ghana is also in the process of formulating a national pharmaceutical sector development strategy.

10. Strategies for Developing Local Pharmaceutical Markets Needed Initiatives and Interventions A multidisciplinary and coordinated approach coupled with systemic investment and development of local pharmaceutical sectors in LMICs can help make access to medicines more feasible and sustainable. Interventions such as the following are critical: • Creating an enabling political environment with strong government commitment to prioritize the development of local industry. It is necessary to articulate a clear long-term vision, as pharmaceutical sectors take several years of investment to become sustainable. • Strengthening Regulatory Systems, which is necessary to ensure access to quality assured medicines. In addition efforts to achieve regional harmonization, such as those being advanced by the African Medicines Regulatory Harmonization program, can also incentivize LPP by aligning regulatory requirements and processes across multiple countries. This can provide an opportunity to expand market access by tapping into larger regional markets.

11. Strategies for Developing Local Pharmaceutical Markets Needed Initiatives and Interventions • Stimulating local markets can lead to the growth of local pharmaceutical sectors. This includes setting differential or preferred procurement and/or pricing practices for local companies, restricted lists, facilitating the import of raw and packaging materials, and supporting technology and knowledge transfer. These types of interventions can help to level the playing field for local companies.

12. Bangladesh Case Study Prior to the 1980s, Bangladesh was home to only about 20 small national pharmaceutical companies. Recognizing the serious challenges the country was facing in providing affordable medicines for its population the Government introduce the National Drug Policy (NDP) and the Drug Control Ordinance in 1982. The aims of the NDP were to: • promote LPP (including raw and packaging materials), • reduce the cost of pharmaceuticals, • remove harmful or useless products from the market. The related Drug Control Ordinance: • prohibited the sale of certain medicines • limited pharmaceuticals from being imported if the drug or its equivalent was already produced in Bangladesh • allowed the government to fix drug prices.

13. These changes led to the following transformational changes in the sector: Bangladesh Case Study

14. Conclusion Access to quality-assured essential medicines is fundamental in supporting the Global Health Security Agenda and moving toward universal health coverage. However, access relies on a healthy pharmaceutical market that is responsive to the needs of people. Local production of medicines can help address the market deficiencies and support more even and equitable access to medicines.