The red tape is actually hundreds of millions of dollars that some private party has to cough up to fund clinical trials, and with many of these drugs, there is no hope in recovering because they’re not patentable. And we don’t really have any mechanism for publicly funding clinical trials for unpatentable but public-benefitting drugs.
Has to cough up millions under the current system. A rule change to make that process easier would be helpful, but an agency which receives over half its funding directly from the industry it oversees is not likely to make policy which damages those same companies.
Not really. Clinical trials are expensive because clinical trials are expensive. Especially when you’re looking for weaker and weaker effects in more specific populations.
There are a number of things that can be done that can fix the broken system while retaining the things that work in our existing system.
1. Public funding for approval for public interest drugs that immediately are available at generic-level prices.
2. Public funding for patent early buyouts so that they can be available at generic-level prices sooner.
3. Public drug bounty systems: award non-trivial payouts to companies that discover and perform all clinical trials, and immediately make the drugs available to the public at generic-level prices.
4. Broad cooperation and alignment on approval trial requirements across drug regulators in Canada and the EU, such that drug trials don't need to be duplicated 3 different times in 3 different jurisdictions with slightly varying rulesets. This would benefit both public interest ideas above as well as existing private interests.
5. Add price controls to drugs which have benefited from publicly funded research. I'm not a fan of price controls in general as I think there is a risk that good drugs won't be researched if they're too risky, but in the case of a private company taking some compound that public research discovered, patenting the chiral[0], and funding the clinical trials for it...the public has already done all the hard work and you're just
6. Allowing for risk-assumed early approval drugs which are regulated for content purity, but which do not do full testing for drug interaction/benefit/risk assessments. Users could explicitly opt out of the guarantees that come with full FCC approval. This is actually how the much of the developing world treats drug regulation: sure you can buy it and it will be what it says on the label, but there is no guarantee that it will fix your problem or that it wont harm you. While that sounds potentially troublesome, there is a reason why rich people sometimes travel to poor countries for medical care, and this is a huge part it. If you've got 9 months to live, you don't care that the FDA is trying to determine if it might kill you...you are already on your death bed. Holding back a potential cure is inhumane.
[0] https://en.wikipedia.org/wiki/Chirality_(chemistry) Chirality is an extremely common loophole that allows drug companies to patent drugs that work exactly the same as an unpatentable drug, so that they have price protection for it.
As an alternative to some of these, do you think that compulsory patent licensing could work? This would allow for day one generics while still ensuring that the parent holders get paid.
