Sakthivel Selvaraj, Habib Hasan, Preeti Kumar, Maulik Chokshi Public Health Foundation of India, India 1

Background Access to medicines is critical to the provision of equitable, affordable, and quality health care in low- and middle-income countries (LMICs). According to WHO estimates, the mean availability of essential drugs in LMICs is 35% in public sector facilities and 66% in the private sector. Also, in India it differs between states. Medicines also account’s for a high proportion of households out-of-pocket (OOP) expenses, accounting for as much as 70% of all households’ spending on health care. 2

Background Despite improvements in terms of price and availability, data on access to and use of medicines is often weak. Even where data are available, there is limited contextual evidence and weak capacity for analysis and interpretation for development of sound policy options. The aim of this research is to enhance the use of evidence in policy formulation to improve access to medicines in LMICs. This study uses the framework of the Access to Medicines Policy Research project developed by the Alliance for Health Policy and System Research (WHO) to identify priority policy concerns. 3

Objectives Identify and rank policy concerns in respect to access to medicines, as perceived by multiple stakeholders, such as health planners, policy makers, civil society organizations, communities, and patient groups in India and its states; Identify and rank the related policy research questions in the field of access to medicines in India 4

Methodology Design: The study has three components: a literature review followed by a survey of key informants through structured interviews to identify priority policy questions and finally ranking of policy questions in cardinal order (1 being most important) in terms of terms of priority and feasibility Setting: This study is conducted at national and state levels in India, covering both private and government institutions. Study population: As part of the review exercise, national- and state-level published and grey literature, policy documents, relevant reports, and prior priority setting exercises in accordance with the selection criteria were inventoried. 5

Methodology In addition, we have registered the policy statements and concerns of various stakeholders. As far as the survey is concerned, the key informants were selected according to their significant involvement at different levels in medicines issues, especially high-ranking officials of the central and state governments (including Ministry of Health, Department of Pharmaceuticals), civil societies, academic researchers, pharmaceutical companies and industry confederations, etc. Outcome measure: Specific constraints related to access to medicines are identified according to the 4 areas of WHO Framework for Equitable Access to Essential Medicines at different levels of health systems. 6

Methodology 7 Key informants A total of 26 interviews involving multiple stakeholders were carried out. Category of respondentsNumber of respondents Academics3 CSO/Consumer groups/Cooperatives5 Central Government Representatives5 State Government Representatives5 Drug Manufacturers/ Industry Representatives4 Multilateral agency + bilateral agency4

Results Overall 49 questions were identifies through key informant interview and literature review, they were then converted to sub-set of 19 questions for which the priority ranking exercise was conducted. These 19 questions were concentrated across following domains drug financing and prices, rational drug use, research-development-patents, regulation and governance. 8

Results Drug financing and pricing What should be per capita financial allocation to ensure access to medicine across the country, and how should one address inter- state and intra state disparity? With recent advances in heath care payment mechanism and increasing role of insurance companies as intermediaries, what should be the reimbursement mechanism of drugs? Is Drug Price Control Order (DPCO) effective? Is there a possibility of relooking at DPCO? Is there an opportunity to expand DPCO? What is the current Monitoring and Evaluation system on drug prices and availability? Is there a need of centralised agency to do that? Is there a need for strengthening and expanding the role of NPPA, especially with new IPR regime? 9

Results Rational drug use What kind of policy environment would ensure implementation and enforcement of the concept of EDL and STG's across the health system? How do we ensure continuous availability of essential drugs across all health facilities? What is the best modality to regulate production of irrational medicines by pharmaceutical companies, dispensing by retail pharmacies and prescribing by private physicians? 10

Results Research developments and patents Is the current resource allocation to Pharma R&D in sync with the health care needs of the country? How can one create an organisational and institutional structure, creating an environment for faster technology transfer, for the benefits of the people? How to balance innovation and health system needs under the emerging IPR regime? On which issues should we have a non negotiation policy as far as IPR is concerned? How does one ensure that with progress on negotiations on IPR, safeguards are in place to protect small and medium enterprises (SME)? Is there a mechanism of financing, which can integrate entire drug development process? 11

Results Regulation and governance What are the current regulatory gaps? How does one fill those gaps and ensure uniformity across the country? Is there a role for SME to ensure drug security in India? How does one ensure indigenous production of Bulk Drugs/Active Pharmaceutical Ingredient? Is there a role for PSU’s (Public Sector Units) in manufacturing quality affordable drugs? Is there a need for an agency like National Institute of Clinical Excellence (NICE) for health technology assessment, undertaking outcome research, before reimbursement? Can a centralised procurement agency ensure availability of good quality drugs in a decentralised distribution manner at the state level? 12

Results Our evidence highlighted wide disparities in drug expenditures across states in terms of per capita resource allocation. Except for the Drugs Price Control Order (DPCO), there are no other policy instruments to manage drug prices, especially for the innovator drugs and for those not under DPCO. Lack of communication, coordination, cohesion, and coherence among various institutions/ministries has been observed, which has significant implications for access to medicines. 13

Funding Support: This work would not have been possible without the financial support from Alliance for Health Policy and System Research (WHO). Their constant encouragement and support to this study are highly appreciated. Institutional Affiliation Disclaimer: This research report is based on a study conducted by researchers based at Public Health Foundation of India, New Delhi. The views expressed in this poster do not reflect the views of the institution. Any errors and omissions are those of the researchers themselves. 14