Healthcare is a highly complex and dynamic sector. Although it features many typical market dynamics and rules the healthcare sector is prone to product and market failure (Toumi, 2017). It is therefore of utmost importance that healthcare regulation and resource allocation is purposeful, maximises the utility of available care options at the right point in time and is (considered) fair. As immunisation is an excellent public health tool that can protect entire populations from harm, it is particularly important that introduction decisions are based on transparent and accountable evaluation procedures. We demonstrate that it is possible to establish a vaccine expert-based consensus on a core set of decision criteria (priorities) to be taken into consideration by NITAG members in their vaccine introduction decision procedures. We also demonstrate that including these priorities in SMART Vaccines, a vaccine specific multi-criteria decision analysis (MCDA) tool, would substantially increase the transparency and accountability for reasonableness of SMART Vaccines-based decision procedures. As personalised care and prevention are being recognised as the central plank of dealing with increasing healthcare expenditures, and the primary care setting is ideal for early detection and prevention or postponement of many (non-communicable) diseases, we developed a roadmap concept for re-orienting, in a first step, the primary care health system. Naturally, mobile and smart diagnostics, devices and applications, to be utilised outside of the clinical setting, can facilitate the collection of real-world data in so-called virtual clinical trials (VCTs). However, VCTs are not commonplace as of yet, in particular in Europe. We found that challenges pertinent to general awareness, technical validation and usability of smart devices, data processing, regulatory review, and suboptimal collaboration of stakeholders persist and prevent the broad adoption of VCTs. The findings of the VCT study also highlight some potential challenges but also facilitators for the adoption of the dMC concept. Some challenges identified in the VCT study, in particular those relating to user-centred product design and stakeholder information/data needs, could also be largely addressed by the proper collection and analysis of market intelligence. As even basic market research is not commonly performed by academic entrepreneurs and SMEs and lack in expertise and resources is a prominent barrier, we elicited from experts which market research considerations they consider particularly important and created a market research toolbox for the biopharmaceutics sector. A common theme across all considerations is information asymmetry of innovators towards important stakeholders. Conversely, and in particular in emerging technology fields, R&D activities can outpace regulatory oversight. Currently, there exists paucity of regulatory protocol harmonisation regarding the review of marketing authorisation submissions for live biotherapeutic products (LBPs) – including health claims – in Europe and the USA. To reverse the rationale of the previous study, we collected information from innovators, namely recent patenting activity, to cross-inform regulators of potentially upcoming LBP-technologies that might require regulatory oversight in the near-to mid-term future. We found that overall patenting activity for LBPs is in decline, and heavily concentrated on the Chinese market. Despite the decline, we identified some prominent relative increases for less expected targets. Involving affected stakeholders in innovation processes and exploiting various means to decrease information asymmetry among them can considerably increase resource utilisation efficiency, focus resources on areas that require further research and thereby close knowledge gaps, and reduce frustration and friction caused by exclusive health decision making criteria. Involving and empowering all affected stakeholders to take part in various innovation-related processes and in particular providing patients with the technological means and literacy to better maintain and improve their own health and autonomy, are of paramount importance for the future.
|Award date||13 Dec 2021|
|Place of Publication||s.l.|
|Publication status||Published - 13 Dec 2021|