Healthcare system reform

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Scenario wherein the healthcare system is more integrated, shorter lines between pharma, medicine, insurance companies, which gives pharma incentive to focus more on market pull than technology push

• • These are just items to be harmonized in the scenario story**

At the beginning of 2009, the global economic environment was still in a major state of flux.In the United States, the actions of the Obama administration and Congress were committed to addressing healthcare issues as part of economic reform. The global economic slowdown sparked acceleration of reform in other countries as well, whether in the form of increasing government demands for price cuts, as in Germany and the U.K., or encouraged use of generics, as in Japan.

In the U.S., in Europe the pharma industry is seeing a shift away from the model in which the physician is the major stakeholder. Payer organizations comment RED: we use insurance companies as payers, it would be good to have the same jargon in all of the scenario's are taking on a more significant role, the distribution landscape is changing, and patients/consumers are taking on a larger role in healthcare decision making.

Pharmaceutical executives have taken some action—for example, increasing integration of the commercial and development sides of the business to ensure the commercial relevance of scientific and clinical innovation. The commercial side recognizes the declining value of the heavy “push model” of physician sales and is trying to redefine frontline marketing Comment RED: this is interesting: it could be used as a contrast also to cocktail bar: there the advertisement towards patients is expected to increase actually, we could add that there. In this model, probably not. Operationally, companies are streamlining, but are also taking a leadership role in adding safety and transparency in the supply chain. These initial moves make sense and are starting to take hold, but we believe that most of the industry must do much more to back up intentions with successful actions.

Another track of the regulatory side was also moving forward. Started by the FDA’s Sentinel initiative, launched early 2010, sets out to provide access to existing electronic health information, including claims data, emerging electronic health records, and diagnostic databases. The primary aim of the FDA was using these databases to monitor the safety of drugs and devices, and the Sentinel database will likely support Phase IV post-marketing studies and surveillance. Can be added: In Europe a similar initiative was already taken in a number of countries, like the Netherlands with a system called Aorta (Electronic Patient File, EPD) see [[1]] (in Dutch), Sweden and Belgium (although implementation seems harder [[2]]. European Union followed US did not follow them, US followed European initiatives...Dutch system was already started in 2008 with similar legislation and allowed controlled sharing of electronic health care information by 2013.

As expected, ICT industry moved quickly to capitalize this new market opportunity. Two of the biggest ICT giants Microsoft and Google has both launched their respective services where health and fitness information of the individuals can be stored online. In fact those services provided as the early integration infrastructure for the healthcare stakeholders. ... Pharmaceuticals started to shift away from physician-based models to focus on non-physician customers such as payers, pharmacies, and patients.

Due to the increased financial pressure from both government and insurance companies integration started first between pharmaceutical industry and payers. Successful pharma companies started to work with payers in joint pharmaco-economic studies that will allow them to create value through joint programs and capabilities to deliver benefits and manage risk.

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.

Comment RED: main driving force seems to be costs. It is not payable anymore, therefore the health care system needs to reform. The below more fits with the pharma valley scenario.

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.

Comment RED: this next part can possibly be deleted in whole: 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

Comment RED: this could also be used in the cocktai bar principle although it is unclear whether it will be big pharma doing it or smaller companies. In google they also start a service to store your own DNA features, this could accelerate the cocktail bar a lot see: [[3]].

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 comment RED: too vague that last sentence...you could say there is a need due to cost, I also think that insurers are faster aligned with this, they find this interesting as well, sicne they see a savings potential.

Comment RED: this is good in principle! The backing of the two parent companies, with their considerable financial clout comment: ICT can pay for it themselves, big pharma is not needed, 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 what is reinsurance 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.

Comment RED: Upon reading I was thinking, why only Europe and US as drivers? Why not countries like China, India, not the right ICT network yet? Let's discuss this this evening

Comment RED: This section below might be more suitable for the pharma valley and cocktail bar parts, wherein the shorter reg track plays a more important role. Here it's an aid, not a necessity. I like the reasoning though

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" Comment RED: I would like to put more emphasis on how the system itself looks like here: what is the myth? I think it it more about efficiency of the value chain than product innovation in itself. 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.

'Comment RED: this part belongs more in the cocktail bar part. 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.