Choosing innovation over regulation for real patient benefit
The term innovation in healthcare means the development of new treatment methods, new drugs and modern medical devices. As the government tries to reform the healthcare system in India, innovation must be explored in a broader context, much beyond its traditional notion.
While patients, aid groups, government and political parties rejoice over the recent ceiling on stents and the latest discussions to include other medical devices in the National List of Essential Medicines, what they need to worry about is that low prices will curb advanced inbound technologies and will deny patients' access to quality products and novel treatments in the long run and undermine their right to choice. It is increasingly getting clear that mere dependence on tactical price ceiling to improve patients' access to innovative life-saving devices will not work, and various angles and perspectives across multiple factors need to be considered in the interest of patients. In fact, a regressive step such as price control on medical devices, if not harmonised, could lead to serious concerns, including delayed or no access to innovative technology, continued rise in the cost of medical therapies and quality concerns of these contrivances.
We need to understand that innovation and access are not mutually exclusive. There must be a middle ground, and a balance needs to be achieved. In the following paragraphs, I will run through the key challenges that need to be addressed and the possible way forward.
Bring more competition to the market
Market competitiveness, with an efficient and effective regulator, can lead to price reduction over a period and ensure return on investment (ROI) for the extensive research and development undergone in the production. If an innovator does not get a decent ROI, there will be no incentive to innovate, thereby limiting advancements in the medtech sector. It could lead to a situation similar to the anti-infective drugs segment globally. With no ROI, no innovations can take place and eventually there is no ammunition left against the deadly resistant bacteria.
Bringing more competition to the healthcare markets not only controls costs but also provides the basic operating environment that stimulates innovation for value-based, high-quality, affordable and accessible healthcare.
Addressing infrastructure barriers
We need to acknowledge that the real barriers that block access go beyond the cost of medical devices and medicine prices, with infrastructure and manpower constraints also contributing to the entire procedural costs. To tackle healthcare issues in totality, infrastructural inefficiencies need to be tackled first. These could be limitations such as lack of healthcare professionals, inefficient procurement and distribution systems, barriers to geographical access, availability and affordability, and we need to outline existing interventions to overcome these barriers.
The absence of an adequate number of trained physicians and paramedical staff invalidates the most revolutionary medical device or treatment procedure as it cannot be effectively used. There is a need to empower patients, first by providing them access to quality healthcare and devices, which are tested in accordance with universally accepted standards and guiding principles, and then by providing them with a better medical infrastructure, better delivery of services, well-qualified and trained nurses and paramedical staff, and, of course, better sanitation, which is everyone's right. All these must be done without increasing the out-of-pocket expenses, which are already very high in India.
A lag in providing the appropriate treatment or therapy can also heighten the cost of treatment. An area worth noting on the long run is the hidden costs of inefficient regulations, with an upsurge of competition in global markets. A coherent approach is needed to eliminate redundant requirements, resulting in improved access to medical devices and safer products for consumers, thereby reducing the time taken for a product to reach the patient.
Patient should be the winner
Advancement in healthcare has not only changed people's quality of life in India but has also increased their aspiration. It is of paramount importance that people should get what they have asked. While I appreciate the relevance of transparency and the need for streamlining prices and empowering the patient, I also believe that all medicinal and clinical judgements should be taken objectively and empirically, for the sole benefit of the patient at the centre. Moreover, these decisions cannot be unilateral. They must involve ethical medical professionals and must be taken in a consultative manner.
The healthcare industry needs a proliferation of innovations aimed at enhancing the quality of life and addressing the efficiency and cost effectiveness of the healthcare system. Patients need to be the winners of this entire effort. While we look at reducing costs, we also need to increase value, improve patients' experiences and outcomes, speed up the translation of research into therapies and cures, and introduce innovative technologies in healthcare, something that people can access at the most affordable cost.
360-degree engagement is the way forward
We need to implement a few measures in the right direction. There is an urgent need for the government to increase stakeholder engagement by treating patients as partners, for an effective healthcare system and access to quality healthcare. The evolution towards patient-centric research is contributing to closer ties between clinical research and medical practice. The world's innovative medtech companies are deeply engaged in finding holistic solutions, partnering in more than 250 programmes around the world that enable people to gain access to the full range of healthcare solutions. To bring these solutions to those in need, it is important to have a broader vision and view healthcare in totality. It requires, on an urgent basis, the identification of the real barriers to access and a strategy formation to address them first.
Bejon Misra is Founder, Partnership for Safe Medicines (PSM) India
