Can we fix the gaping chasm between health policy and implementation?

The race to develop precious new Covid-19 vaccines, followed by complex international procurement and logistics processes, was a new experience for most of us who have had little experience of being powerless when it comes to availing of a medical innovation that can prevent us from becoming seriously ill or premature death. 

Yet every day there are patients across Ireland being denied access to safe and effective therapies for rare, disabling, or life-threatening conditions. The current average approval time for new medicines in the State is almost 500 days¹. This represents a serious lag time compared with our European counterparts – even lower income Eastern European countries can get these medicines to patients in far less time. 

This inexcusable delay is both systematic and bureaucratic in its origins. The HSE spends over €2 billion each year on medicines but a relatively small portion of that is ringfenced for innovative – and almost invariably high-cost – therapies². In the era of personalised medicine and targeted treatments, the level of spend is wholly inadequate and leads to a complete mismatch between the cost of incoming product pipeline and the available funding stream.

One answer to this would be to make the approval of new medicines an independent function by moving it away from the HSE. In the UK, the National Institute for Clinical Excellence (NICE) is much-maligned, but the idea is sound – the independence that it brings helps to detach the clinical evidence from the financial process. Such a body here in Ireland would also change the balance of decision-making in politics, given that this has become a highly politically charged area where political considerations can determine which treatments get bumped up the approval process on occasion. We ultimately need to depoliticise new medicine evaluation and separate the payer - the HSE - from the evaluation process as they do in many other countries.

And many of these countries are light years ahead of us when it comes to offering access to medicines via innovative payment models. For example, in Germany, access to new treatments for patients is instant but the effectiveness of these new therapies is only recognised financially through reimbursement once that effectiveness is proven by real-world data. By implementing a similar model involving surveillance-based outcomes data, we could speed up access to medicines and also take advantage of the new targeted approaches to new medicines in a way that would ultimately decrease the State’s medicines bill. Accurately captured, real-time, real-world evidence offers a mechanism to make evidence based decisions about which treatments eventually progress and become permanently approved, meaning that only the safest and most effective medicines are funded by the State.

A key challenge is that Ireland currently lacks the necessary databases and registries, as well as the required IT infrastructure to allow for such a data-driven process. The recent Roche Futureproofing Healthcare Index on Personalised Healthcare found that Ireland ranks poorly when compared to our European counterparts in terms of data collection and data sharing. This will come as no surprise to anyone who has worked in an Irish hospital – the basic unit of data storage in many hospitals is still a lever arch file. More typically, a big room full of lever arch files.

That this remains the case in many Irish hospitals and healthcare facilities highlights the gaping chasm between health policy and implementation. Ireland in fact has an excellent eHealth strategy that is enshrined in health policy, but it has ultimately suffered from a lack of political commitment and exchequer investment. An Electronic Health Record (EHR), standard in most European countries, is the most secure and safest form of medical record. An EHR is in use in some pockets of the system (to great effect) but it has not been rolled out on a universal basis. We also have an individual health identifier, a unique identity that would help to follow patients throughout the health service, ensuring continuity of care but also tracking outcomes from new medicines. This already exists and is underpinned by legislation, but the systems required to facilitate are the missing piece. Again, funding and leadership are the stumbling blocks.

While there have been historical failures in IT project implementation such as the PPARS controversy from 2005, we cannot be a prisoner of such past failures³. There have been many successes since then.

The approval process for new medicines is fundamentally broken and needs to be rebuilt, piece by piece. This will not happen overnight; tactical, stepwise implementation will ensure success, rather than a “big bang” approach. When we consider the expedited approval and procurement process involved in the mammoth task of getting the Covid-19 vaccine to everyone in the country, we realise that unnecessary red tape can dissolve almost instantaneously if the will and the leadership is there. Embracing technology can only improve the patient experience and ultimately get them quicker access to the medicines and treatments that they need.

References: 

1. https://www.irishtimes.com/business/health-pharma/state-slower-to-adopt-new-drugs-than-most-of-western-europe-1.4579392
2. https://www.globallegalinsights.com/practice-areas/pricing-and-reimbursement-laws-and-regulations/irelan
3. https://www.siliconrepublic.com/enterprise/plan-or-be-damned-warns-expert-on-ppars