The issues and problems surrounding drug discovery are getting not only complex, controversial but difficult. The reject rate and withdrawal of a promising new drug has become an almost common phenomenon. The late realization and stringent regulatory practice is able identify the black sheep very early and put a ban on the molecule. It is very good and appropriate as for as the patient safety is concerned however this practice is also showing a negative impact on R&D activities concerning the drug discovery and development. The conventional model of giant pharmaceutical super power house is collapsing on its own issues of sustainability. It is struggling to sustain as it is difficult to maintain big portfolio of scientific human resources and run mega drug discovery programmes like in the past. The poor productivity of Research and Development (R&D), increasing cost of new drug development, fierce competition by the generic industry has altogether pushed the big MNC to walls, resulting in adopting changed cost cutting economic policy and functioning, in which the super pharmaceutical bigwigs are closing on by resolving to close down R&D centres and laying off the excess staff from the portfolio of R&D programmes, outsourcing the jobs to Contract Research Organizations (CRO) in developing countries. This has downsized the research capacities of MNC and is not effective as they were to be before. It is altogether a natural but slow death blow to the mega R&D ventures. The risk of failure amidst of clinical trial or in post marketing surveillance period is one of the most haunted night mares of a drug development centre. All this has resulted in deprivations of funding by private entrepreneur to venture into new drug discovery challenges.
On the other hand, the disease patterns and pathology is constantly changing making the existing molecules redundant, by resistance or renewed pathology and toxic effects, which have surfaced due to practice pharmacovigilance programmes. The pharmacovigilance programmes are becoming essentially a regulatory requirement as many drugs were reported to be toxic and are not worthy of usage due to tilted risk-benefit ratio.
The challenges of Diabetes, Malaria, Hypertension issues of effective drugs remains unattempted although there exists real challenge and scope. Instead we are finding the R&D are spending their resources in ever greening the existing patents instead discovering the new molecule. There is an at most need to develop new technologies which can help to manage the bottle necks in the issues in therapeutics of most of the diseases across the world.
There is a need to rethink afresh regarding funding structure for drug development and R&D financing for new drug discovery programme, as the present system is becoming less productive and more expensive. The governments comprising of financing capability with its infrastructure is capable of being alternative to corporate financing or venture capital for drug discovery and development. The government being the investor in discovery projects can direct and control the programmes. The commercial interests being minimal in a Government funded programme, there can be a hope of focused drug discovery programmes which can address the real issues sideling the research for profit and market.
Incentive for R&D programme
The Government gives generous subsidy and incentive for R&D programmes to promote the private industries to take up the responsibility of leadership. The Government never questions and asks the Industries regarding the outcomes of the Government policy which goes without being accounted as these are considered as privileges, without any tags by the beneficiaries. The Government has an expectation from industry that these investment of Government would result in building the infrastructure for the nation. Outcome of this Government investment to build national capacity is going as a waste due to lack of monitoring the programmes. The corporate world should realize the value of benefits derived by Government is in fact based on expectations of return on investment by the Government. Unfortunately, weather it is national or MNC are rarely bothered about the health issues the people face and are so much self centered and over focused on their profits and shareholders, they are limited in their vision to provide the leadership to revamp the health care system of the country.
The overall outcome of the above model is really nil in terms of new drug discovery and establishment of niche R&D facility for the country. The growing problems of disease burden and development of antimicrobial drug resistance has threatened with return of epidemics which haunts every low and middle income countries due to compromised poor sanitation and malnutrition. There is a need to invent new models for drug discovery which starts making attempts in drug discovery focused on country needs and comes out with cost effective answers of sustaining and delivering health care system.
The national facilities of drug discovery and the university departments based research can be one of such alternative. Looking at the US and Europe model, like National Institute of Health and EMBO which are considered as leaders in research and also have enough infrastructure facility to conduct a sophisticated research programme of public interest. We can also develop such institutions of drug discovery, for example CDRI, NBRI etc. On other hand the professional societies and associations for not for profit can be a viable, for example, American Diabetics Association, Alzheimer Association and Kidney Foundation are doing an exemplary work which has commitment to help the patients. In case these associations are encouraged to start the R&D work in the area of the association, these associations would work with passion, which can result into a breakthrough in the drug discovery.
The high cost of biologic medicines appears mainly due to corporate greed which has caused several humanistic issues like violation of practice of human values and ethics. To build an effective system of price control of expensive medicine, the Government should start investing in potential drug molecules of its interest from inception. The Governments are unable to control the scenario as the issues of patents come in. The government itself becomes the partner in drug discovery by investing in R&D, while in development stage. There can be a private/public funding for R&D issues through which the Government can hold some control over the price of the medicine.
(Author is with Dept of Pharmacy Management, Manipal University, Manipal, Karnataka 576104).