Healthcare system reform

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Scenario wherein the healthcare system is more integrated, shorter lines between pharma, medicine, insurance companies

Developments in time

2010-2015

During the first decade of the new millennium, innovation in the healthcare system was primarily dominated by multinational companies. The most important factor contributing to this long term resilience of the drug-based innovation model, and its dominant role in the development of health care systems, was the regulatory system. The primary markets, Europe and USA, have a very lengthy, expensive and complex set of regulations which imposes significant constraints on the innovation system for drugs thus making the product-to-market process tedious and costly.

This was clear when comparing the lightly regulated information and communication technology (ICT) sector with the heavily regulated life sciences, the former sees a much greater degree and rapidity of change in products and capabilities arising from technological innovation and small start-up companies are able to build up rapidly to become major players on the basis of innovations that effectively challenge the status quo. At the beginning of 21st century, it was expected that biotechnology would have a similar impact on health care industries. But also it has played an important role in their development, this has been mainly supportive for the prevailing model of drug discovery, rather than challenging it. Despite large scale public and private investment, the sector is still dominated by a similar set of companies (although their names may have changed) and the basic innovation model remains fundamentally unaltered. Regulation formed primary cause for this result by creating an insurmountable barrier to entry for any start-up company with an innovative idea that might challenge the status quo.

Around 2010 after the 2008 financial crisis, regulators began to see their role in a much more proactive way and not as passive responders to events. In line with “new governance” agendas and linked to globalization initiatives, discussions began to take place within regulatory bodies about their role in stimulating changes in the processes and outcomes of health care innovation. But as like any other regulatory issue, turning this concern/discussions was taking a long period.

Meanwhile next to the advancement in biotechnology, after dotcom bubble, the IT world started to increase innovation pace. Especially Apple's IPhone and later Google's Android products turned mobile phones into handheld computers transformed society to 7/24 online community and shifted the paradigm.

Thus fundamental, rather than incremental, change becomes increasingly inevitable, but also increasingly unimaginable. Some time in the future, the science and industry innovation system will experience a “Black Swan”.

2015-2020

Collaboration between big pharma (? Pfizer, Roche?) and big IT (Apple or Google) companies to form joint ventures (PATC) with a major ICT firm in order to gain “first mover” advantage in what they by then perceived was “the way forward” for the health bioeconomy. It took several years from the formation of PATC to develop an effective model for the new co-ordinated mode of operation which became known as Networked Health Care (NHC).---Why and how it happened was not explained

The backing of the two parent companies, with their considerable financial clout, was reinforced by the support and active participation of two other major financial players, the private health care insurance industry, particularly in the United States, and the re-insurance industry. Other key supporters that were actively involved in the shaping of the NHC approach included the regulators (FDA and EMEA), the major charities funding health care research and development, and a Patient Group Consortium that had been formed in 2012 to promote innovative change in the health care sector and that had mounted a campaign to encourage the more rapid development and uptake of biotechnology-based innovation in 2017.

Change of the regulatory system A series of creative think-tanks was set up, initially involving a restricted set of participants from the full range of life science companies, ICT companies, regulators, and insurance industry representatives. As discussions progressed and concrete proposals began to be formalised, discussion fora were widened to include patient groups and other stakeholders.

The challenge for the regulatory system was to ensure the continued safety, quality and efficacy of new drugs within a system that was responsive to the new challenges being presented by life science innovation.The new regulatory approach that began to emerge required creative and constructive thinking from senior managers, regulators and analysts in life science and ICT industries, along with an enthusiasm for collaboration across non-traditional boundaries. An additional drive that facilitated change was the involvement of Indian and Chinese companies and regulators. Their pre-existing expertise in ICT industry provided the competitive advantage to move to a more equal competitive position with companies in the United States and the European Union, and in some cases even to overtake them in global competitiveness.

The major change of new regulatory system arised late 2018 where there was a revision of the approach to Phase 3 clinical trials, referred to by some as the “Survival license”. Instead of classical double blind controlled clinical trials, individuals volunteered for the test of drug with the benefits and the risks of the treatment. Thanks to the connectivity technologies, main indicators of the patient is monitored by testing organization as well as regulatory bodies and local health practitioners remotely. The new approach helped not only to reduce numbers of patients required for expensive Phase 3 clinical trials but also the earlier rejection of defective drugs from clinical trials, again saving money. However, combined with pharmacogenetics, this approach also led to a significant increase in the number of new innovative drugs on the market, also stimulating a new round of basic research into new druggable targets.

2020-2025

Reform established, result: a "Networked Healthcare System" Gene sequencing plus synthetic genomics is an example of a convergent technology, combining chemistry, physics, engineering, biotechnology and information technology to develop health care diagnostic and delivery systems operating at the nano scale. Such developments were facilitated by the existence of the new NHC based companies that could organise the collaborations across different disciplines required to bring such products to market.

Blockbusters mainly disapeared and a large number of lower margin products which target specific customers reached the market. Overall that resulted in a better financial performance of the involved companies compared to old model multinational pharma's.

By 2025 research on stem cells had resulted in successful and affordable therapies, based on both adult and human embryonic stem cells. They had reduced drug bills and done away with some important drug markets.