The UK Labour Party Document, “Medicines-For-The-Many” is 52 pages long, including 9 pages of end notes. It is an ambitious document. The document discusses, in some detail, innovation as well as access and affordability. The reforms proposed include measures that can be implemented in the short term, but also very transformative policies that would take longer, and be implemented progressively over time.
A number of policies are endorsed in the document, including the use of compulsory licenses on patents including but not limited to through UK Crown Use laws (3.1), public sector manufacturing of generic or biosimilar products (3.4), and policies to expand access to and affordability of medicines that rely on publicly funded research (3.2). There is extensive discussion of the need for more transparency (2.2, 3.2), including a mention of the negative role the UK played in the recent WHA negotiations over transparency (Page 36).
The extended discussions on delinkage were the most forward looking. An entire chapter (3.3) discussed delinkage.
The following are quotes from the text dealing with delinkage, including the nuanced relationship between patents and delinkage, and feasible implementation strategies, including by progressively shrinking term of exclusivity in combination with progressively expanded research subsidies and market entry rewards.
3.3 Research, pilot and expand new incentives for pharmaceutical innovation through delinkage
In the current model, health innovation is rewarded by the promise and incentive of monopoly-based profits, leading to expensive medicines which often fail to meet public health needs. By changing the incentives that determine what kind of health innovation happens, public health can come first, while rationing and denial of access could end. Policy steps can be taken immediately to start the process of changing incentives in the system, however the impact will be felt over a longer-term period due to the development time required for drug discovery and innovation.
Delinkage is an innovation model based on the premise that the costs and risks associated with R&D should still be rewarded, but that the incentives for R&D can be provided by means other than financial returns from high product prices during the period of patent protection.
Innovation is instead supported through upfront grants or subsidies and rewarded by a variety of prizes, including innovation inducement prizes, market entry rewards, or open source dividends.. cxxx These incentives, and the kind of innovation they reward, can be focused on agreed health priorities informed by multiple stakeholders rather than ceding this role entirely to pharmaceutical companies, as is the case in the current system. By replacing market incentives we can ensure that urgent public health needs are prioritised, especially those that are currently ignored, like the ones that affect poorer populations or represent low growth markets such as new antibiotics. Furthermore, a much larger percentage of investment in pharmaceutical products will go directly into R&D.
These alternative incentives can either replace patents or be used alongside them, since patents can be managed so as not to result in high prices. cxxxi For example, patents could play a role in terms of defining authorship of research and the claim to the prize or market entry reward revenues, cxxxii but the patent holder would freely license their technology or license it for particular purposes (eg, for use in public hospitals or by researchers). This would be included within the stipulations of the contract of the delinked mechanism in use, whether that is a research grant or a milestone prize. The crucial element is that the new incentives replace the market exclusivity element of a patent or any other exclusivity. cxxxiii
Transitioning to delinkage
Delinkage is a transformative proposal that creates a completely new incentive structure for health innovation. Moving away from the current system of patent monopolies, exclusivities and high prices to a fully delinked model would require international consensus, just as the global intellectual property model does. This cannot happen overnight but would require a process of gradual transition over many years. The policies to manage this transition are known as progressive delinkage, where incentives are introduced over time in different disease areas while simultaneously reducing prices.
A first step in this direction would be a feasibility study (see Box 9) to test the impact of introducing shorter exclusivity periods for drug monopolies as a way to transition to a delinked model. The evidence from such feasibility studies, combined with other studies conducted by other countries, can then help inform a roadmap toward a fully delinked global R&D model. However, in the meantime, DFID, which already funds some product development partnerships (PDP) that implement a delinked approach (see DNDI example below), could make it departmental policy for all PDPs and research ventures to follow a delinked model.
Proposed feasibility study on transitioning to delinkage
A feasibility study could be commissioned to look at how the UK (possibly in collaboration with other EU countries) could transition to delinkage. This would involve testing the impact of reducing exclusivity periods of patented drugs while at the same time progressively introducing non-price incentives (such as market entry rewards and prizes). Reducing the exclusivity period of a patented drug could be done through measures such as compulsory licensing (or alternatively, introducing more aggressive price controls) after a drug has generated an agreed target of cumulative global revenue.
By reducing the term of exclusivity we can allow for earlier generic competition, which implies a drastic price reduction and increased access for patients.
The study would estimate the negative impact of a shorter term of exclusive rights (or more aggressive price controls) on the industry-wide incentive to invest in R&D. Simultaneously, the study would estimate how much money a government would have to spend on one or more of the following four mechanisms to incentivise biomedical innovation: (1) grants on early-stage biomedical research, (2) grants on early-stage biomedical research with conditions attached to ensure that research outputs are kept as open source, (3) subsidies for clinical trials on drugs to treat diseases where innovation is a priority, and (4) market entry rewards for drugs that provide a significant advancement in medical benefits over existing treatments. cxxxiv–
A number of groups worked with the UK Labour party and influenced the contents of this proposal, including in particular the UK groups Just Treatment, Global Justice Now, STOPAIDS, and the UK grass roots patient groups working on access to drugs for cancer, cystic fibrosis and hepatitis, as well as academics like Ellen’t Hoen and Mariana Mazzucato, and KEI.