**4. Manufacturers**

Pharmaceutical industry is the primary target of governments and their drug regulators when it comes to law enforcement and policy implementation. Doctors prescribe, pharmacists dispense and patients consume what manufacturers make available to them through ill or well-regulated markets and pharmaceutical supply chains. Therefore, manufacturers are the first to determine quality of medicines and thereby their effectiveness in alleviating the ailments of common masses. They are also the first to determine the prices of medicines and thereby their access to people living under various strata of the society. Hence manufacturers can play a lead role in ensuring health and well-being of the society by making good quality medicines available, affordable and accessible to all sections across the spectrum. However, it is a wellestablished fact that pharmaceutical companies are for-profit corporates whose primary goals are to enhance the worth of its share-holders. Therefore, they do not make all the drugs accessible to all the people irrespective of their paying capacity and that turns them into important stakeholders in pharmaceutical policy development because somewhere a balance has to be struck between access and profits, between investments and returns, between innovation and sustainability and between patents and patients.

Social justice in medical care demands that patients belonging to all sections of the society enjoy an equitable access to medicines irrespective of their caste, creed, color, religion, ethnicity, gender or paying capacity as enshrined under the principles governing universal healthcare, however, pharmaceutical corporates need money for research, development and innovation, major chunk of which is made available to them by either the academics or the governments from the tax-payers money as per the available facts and figures. Although the pharmaceutical industry emphasizes how much money it devotes to discovering new drugs, little of that money actually goes into basic research. Data from companies, the United States National Science Foundation, and government reports indicate that companies have been spending only 1.3% of revenues on basic research to discover new molecules, net of taxpayer subsidies [5, 6].

Cases of anti-cancer drugs Sovaldi and Imatinib and directly acting anti-viral drug used in Hepatitis-C, Sofosbuvir can be cited as classic examples of unreasonable and excessive profiteering by pharmaceutical corporates that eventually blocked access to these life-saving medicines in low- and middle-income countries and led to a spate of litigations following invoking of compulsory licensing provisions by the countries like India. Therefore, for any successful and sustainable pharmaceutical policy development pharmaceutical corporates need to be consulted and taken on board before arriving at any national medicines policy framework. This will ensure that the much-needed balance between profits and public demands, between money minting and patient-care, between corporate and social obligations and between patents and the public good is maintained.

With ever increasing obligations that pharmaceutical companies particularly the generic drug manufacturers have to fulfill as envisaged under various international trade agreements like TRIPS-plus (trade-related aspects of intellectual property right), FTA (free trade agreement), TPP (trans-pacific partnership), RCEP (regional comprehensive economic partnership) etc., it is becoming increasingly

difficult to indulge in trans-national trade of generic drugs owing to stringent patent regimes being invoked to protect innovations and intellectual property rights guaranteed under stiff patent regimes across nations. Several companies like Gilead are entering into trade negotiations and voluntary licensing agreements with indigenous generic manufacturers of countries with a view to restrict use of generic versions of patented drugs like Sofosbuvir locally and escape compulsory licensing provisions while at the same time protecting their data exclusivity privileges. Thus both generic and innovator product manufactures are important stakeholders in the development of any pharmaceutical policy framework related to import, export, pricing, R&D, investments, innovations and patents of medicines.

Doha Declaration on the TRIPS Agreement and Public Health adopted by the WTO Ministerial Conference of 2001 in Doha on November 14, 2001 reaffirmed flexibility of TRIPS member states in circumventing patent rights for better access to essential medicines. In Paragraphs 4 to 6 of the Doha Declaration, governments agreed that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health [7]. Accordingly, while reiterating their commitment to the TRIPS Agreement, WTO member states affirmed that the agreement can and should be interpreted and implemented in a manner supportive of their right to protect public health and, in particular, to promote access to medicines for all. Following this Declaration, at the end of 2015, United Nations Secretary-General Ban Ki-moon established a UN High-Level Panel on Access to Medicines with the mandate "to review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies". The scope of the work of the panel being global and ambitious is likely to address access challenges relating to access to medicines globally. At national level countries need to work on this policy incoherence between justifiable rights of inventors and public health by taking manufacturers and innovators on board during the process of policy formulation and implementation [8].
