Playing on the same team

Amidst growing concern about a financial crunch and heavy pressure to develop new moelcules, the concept of public private partnerships (PPPs) has evolved as an able rescuer to drug developers.

Public private partnerships (PPPs) are increasingly being billed as a solution to global health problems. PPPs have been used as a mechanism to garner additional support for healthcare activity. The World Health Organisation (WHO) considers partnerships with governments, not-for-profit organi-sations etc as 'bringing together a group of performers to achieve the common goal of improving the health of population through mutual consent on principles and roles.'

PPPs can greatly alter the growth of the pharmaceutical and biotechnology sectors in India. Corporate bodies have recognised the value of public health initiatives as a long term objective and a few pharma companies have been involved in drug donation program based on the partnerships. To sum up, it's a healthy understanding between public and private participants though it also entails a bit of uneasiness and uncertanity to accomplish core objectives.

Why PPPs?

The last decade has seen many changes in R&D of drugs to treat neglected and tropical diseases. Pharma companies were compelled to cut back on R&D expenses due to rising drug development costs, which had in turn resulted in decreased discovery and development of new medicines. This critical scenario led to the concept of PPPs which bridges the translational gap between clinical development and basic research. It could be made possible by using the expertise from public sector, pharma industry and academia. Inspite of spending huge sums on drug development, only few of the molecules make it to the clinic but it's a proven fact that PPP can move compounds quickly through R&D pipeline thanks to a pooling of resources, both financial and intellectual.

Besides mounting drug development costs, marketing activites too add to the cost of medicines, and this makes it a commercially unattractive venture considering the customer base may not have the capacity to pay and the pharma company is expected to make these drugs available at 'reasonable' prices. PPPs have turned out to be an extremely good solution to this problem. Thus besides the product development angle, PPPs are also useful for government-directed healthcare agencies as well as Non-Government Organisations (NGOs) like Bill and Melinda Gates Foundation and the Clinton Foundation, to name just two high profile NGOs, which channel free or subsidised medication to some of the worst disease affected areas on the globe. Nilesh Gupta, President, Advanced Markets and R&D, Lupin believes that working with government bodies like Department of Science and Technology (DST) is a great funding option and companies should certainly try and avail of this opportunity. DST obviously gets a lot of requests, so only the best proposals sail through.

Benefits

"The advantage of encouraging more public and private partnerships is that it reduces the gap between public research institutes and industry, which is very important if India wants to take a lead in science and technology development" - Chirag Mehta Head, strategic planning and development Intas Biopharmaceuticals

"PPP with academia and DST in particular are a reflection of government's intent to encourage pharma research in India. The department has introduced a special funding program 'Pharmaceutical Research and Development Support Fund'." - Nilesh Gupta President, Advanced Markets and R&D Lupin

Curious observers of PPPs believe that these partnerships will reduce concerns related to the investment challenge and specific costs faced by governments and improve quality and efficiency of health services. According to international organisations like WHO and pharma companies, PPPs can contribute to improving equity in access to essential drugs while enhancing research into slightly sidelined diseases like malaria and tuberculosis. PPPs are very important from India's point of view as it is one of the developing nations with the second largest population of diseased individuals.

Chirag Mehta, Head, Strategic Planning and Development, Intas Biopharmaceuticals, opines, "The advantage between encouraging more PPPs is that it reduces the gap between public research institutes and the industry, which is very important if India wants to take a lead in science and technology development."

PPPs have both innovative and positive reflections on public health and they have provided the platform for addressing critical issues by sharing ideas, resources and individual expertise. Dr G J Samathanam, Advisor/Scientist-G, Government of India, Ministry of Science and Technology, DST lists some of the crucial gains of PPPs. He says, "PPPs provides access to public funded government labs and academic institutions. There is an opportunity to get intellectual inputs on the collaborative projects with more young minds. PPPs are a great platform to expand the scientific knowledge as it facilitates opportunity for getting interaction with other scientists. PPPs gives an access for several other state-of-art infrastructures. Healthy criticism through experts is yet another advantage of PPPs. Such partnership makes available the skilled R&D manpower and successful projects deliver Intellectual Property Rights (IPRs)."

Gupta echoes Samathanam's views. He says, "In addition to the funding, the main advantage is the guidance provided by authorities connected with bodies such as the DST. If ramped up, the approach followed by DST could change the face of drug development as is done in India. There are a lot of great institutes and companies which have great ideas but don't have the funds to carry it through - the DST approach provides people the opportunity and the ability to realize these aspirations."

Pitfalls

Though PPPs are conceptually appealing, there are many concerns as well. The governing methods and structures under which PPPs operate have been criticised. The time period of collaboration between industry and public institution and lack of proper commercial vision are some of the major stumbling blocks for PPPs. Mehta says, "In terms of PPPs currently in existence in India, there are many public institutions that have done good basic research, but the research carried out in majority cases is purely successful at a lab scale. These institutes need to carry out research at commercial scales that serves the dual purpose of getting due recognition for application in society and generate business for the institution. Many times, the PPP takes place when the research has reached a particular milestone. In fact, industry and public institutes need to collaborate right from the beginning of the project so that the development cycle is favorable to everyone."

Besides the technical issue, there are some ethical and moral issues that also count in such kind of partnerships. Dedication and trust on both sides is the foundation of such partnerships, especially since it involves sharing and transfer of IP, which could be technology and/or data. However, failure to walk hand in hand degrades the value of the partnership. Necessity to invest certain amount of financial resources, requirement of sincere efforts and catalytic attitude, give and take nature and most importantly patience are some of the pitfalls of PPPs, according to Samathanam.

Government role

The Government of India is playing a pivotal role in the success of PPPs. The formation of the DST was one such step to organise, promote and co-ordinate science and technology activities in India. To meet the challenging demands in basic research, to develop world class centers of excellence in R&D in frontiers of science and technology are some of the key things on the agenda of DST. "PPPs with academia and DST in particular are a reflection of government's intent to encourage pharma research in India. The Department has introduced a special funding program called the Pharmaceutical Research and Development Support Fund (PRDSF). We have two projects in partnership with DST under this scheme," says Gupta. "We believe working in partnership with the DST is great funding option and companies should try and avail as much as possible," adds Gupta.

The Department of Biotechnology (DBT) is also pushing ahead PPP efforts in the country. DBT's brain child, the Small Business Innovation Research Initiative (SBIRI) supports high-risk pre-proof-of-concept research and late stage development in medium and small companies headed by innovators having a science background. SBIRI covers all areas in biotech.

Mehta informs, "DST and DBT have played a major role in extending benefits to biotech companies by means of fiscal incentives, special grants and other tax friendly measures. The government's response to regulatory and IPR issues, development of skilled resources as well as increased allocation of funds with an emphasis on R&D in recent years has made an important contribution towards strengthening the biotech sector."

Partnership with the private sector brings financing to the public health sector. In several instances, it has contributed immensely in improving access to essential medicines in poorer countries of the world and helped to mobilise additional resources. PPPs have provided support for healthcare in the face of declining investments and rising demand for services. However, as Mehta rightly says, the structure of the partnership needs to be constantly evolving and public institutes need not be just technology innovators but should also become an active part of the technology commercialisation process. For many public institutes, this is not a priority and the general feeling is that once research is complete, their work is over.

More than bridging the resources gap, PPPs are one more way of ensuring a cross-fertilisation of ideas and more importantly, attitudes. While industry can do with periodic infusions of altruism, academia may need to learn a few lessons in realism. One hopes that future PPPs will be smoother and more about gain and less about pain.

sachin.jagdale@expressindia.com