Good news! Living in the 21st century means living in the most healthy and technological most advanced times humanity has ever seen. Newly found cures and treatments allow humans to combat formerly lethal diseases and improve the quality of life of billions of humans. While medical progress improves our lives regulatory trends can be observed that might jeopardize future breakthrough innovations.
A cancer diagnosis is not a death sentence per se anymore. Over 65% of patients diagnosed with cancer will live for at least another five years. Scientific progress and better treatment guidelines are the drivers of this massive boost of survival rates.
Breakthroughs in medical research allow us to find better and more effective treatments for so-called non-communicable diseases such as diabetes, arthritis or heart diseases. Death rates from these non-communicable diseases have decreased by 20% in the past two decades.
Developing a new drug takes not just years and hundreds of millions of Euros but also thousands of clinical dead ends in research. Once a company has found a potentially effective new drug it has to go through a very comprehensive process in order to demonstrate its safety and effectiveness before receiving regulatory approval.
In order to compensate innovative companies for the time their new product got caught up in regulatory review the European Union designed an instrument called Supplementary Protection Certificates (SPC). SPCs compensate the inventor for the time needed to obtain regulatory approval for his product by extending its market exclusivity by this time. One could call SPCs also an insurance against red tape.
While we should all salute to medical innovation curated by biotech and pharmaceutical entrepreneurs making our lives better and longer there is also political resistance towards innovation in the marketplace.
The European Union is currently reviewing the compensation scheme for innovation and invites civil society, patient groups, academia, and industry to contribute to this process in a dedicated consultation process.
This EU consultation process is very complex, preventing key stakeholders like many smaller patient and consumer groups or individuals from submitting their view on protecting research investments from red tape. While this consultation process should serve as a tool for engaging as many stakeholders as possible and practise a transparent policy making process the EU advises interested parties the hiring of lobbyists and technical advisers to submit comments.
The complexity of the consultation process and the political will of some players in the European Union to fully shift compliance costs from the regulator to the innovator poses a threat to the innovation climate in Europe. Given that the EU hosts some of the most innovative companies in the world this could have a global impact on finding new cures for old diseases.
Should we be satisfied with the level of technological progress humanity has reached in the past century and commoditize every breakthrough innovation of the past years right now? This might allow a short gain of accessibility but could lead to disincentivize expensive and highly regulated medical research. Curing all cancers, helping people with orphan diseases, finding a vaccine for HIV, and combating dementia are huge challenges for the medical research community and life science entrepreneurs. By scrapping SPCs and thus putting the full burden of government red tape on the shoulders of those who invest in medical research might be detrimental for patients that are still hoping for a cure of their condition.
The fact that in 2017 over 133 orphan diseases can be treated is great. Especially given that just two decades ago we merely could threat eight. Nevertheless we should keep in mind that there are thousands of rare diseases that still need to be researched and found a cure for. Crippling innovation could be a death sentence for those who have to hope for medical breakthroughs.
