Relevance of policy in shaping personalised medicine and tackling lung cancer
Policymakers have a significant role to play in bringing about a Europe in which personalised medicine, in all its forms, can be integrated into healthcare systems. Denis Horgan, Executive Director, European Alliance for Personalised Medicine, argues that a lot remains to be done to help Europe realise the promise of personalised medicine
Personalised medicine is changing the way we look at and respond to cancer. The concept of personalised medicine is not new. It has already emerged in the here-and-now, and its influence is growing everyday. This exciting change relies on new technologies (genomics etc), Big Data and better-targeted clinical trials, among other aspects, in order to deliver the right treatment to the right patient at the right time.
Lung cancer is the leading cause of cancer related deaths throughout the world, and treating the patient with therapies that are predicted to be effective based on the molecular characteristics of the tumor, can certainly add years of life for those patients whose tumor harbour specific abnormalities. Recent advances in personalised lung cancer medicine can dramatically change an entire treatment paradigm.
However, there are several practical barriers in realising the full potential of personalised medicine, and policymakers have a cruicial role to play in overcoming these barriers in order to kick-start a new wave of cancer treatment.
There is a need for more research, education programmes, incentives for innovators and, not least, better regulation and commonly accepted (and widely implemented) best practices.
While it is true that healthcare remains a member state competence, the EU as a whole is becoming more involved in various aspects (legislation, clinical trials, cross-border healthcare, data protection and more) which, theoretically at least, span all 28 EU countries.
Product approval, for example, through MAPPS (Medical Adaptive Pathways to Patients) is aimed at getting innovative treatments/medicines onto the market much more quickly than has been the case, in order to potentially save lives.
But the EU cannot act alone, member states have to adapt, take a look at their Health Technology Assessment/approval procedures and collaborate much more with their fellow EU countries across borders in many spheres, including the sharing of knowledge and research (to avoid duplication, and the pooling of Big Data).
It is evident that the EU, in tandem with member states, needs to ensure the proper transposition of its legislation and policies regulation at a national level. More work needs to be done on agreeing treatment guidelines, and encouraging their implementation, quickly and effectively.
All member states look at healthcare from a different angle, sometimes due to wealth (or lack thereof), a high (or, indeed low) incidence of a particular disease or diseases in its population, the cost of pharmaceuticals, cross-border payments to patients, the strength of patient advocacy and more. There are often many more differences within the regions of the larger nations. Clearly, optimal treatment is not being offered in every country and the above are only some of the reasons. Ineffective or non-existent cross-border collaboration, meanwhile, only adds to the barriers to access for patients.
So what should policymakers address to fulfil the vast potential of personalised medicine?
Innovation is key to progress. As things stand, there is a surfeit of incentives to promote investment in developing diagnostics. Experts note that coordinated timing when it comes to reimbursement and approval of a companion diagnostic is essential. On top of this, the transferring of technology and public health assessments differ from state-to-state.
The translation of research is another key issue. This affects both treatment once a disease has been discovered and, importantly, prevention – with all the cost savings that go along with the latter, not to mention continuation of the best quality of life.
Translating cutting-edge research effectively in the arena of personalised medicine will save lives and lower costs.Education is another vital cornerstone.
Policymakers should fully understand the needs of modern-day patients and how personalised medicine has the potential to change healthcare for the better. They must be aware that it is vital to develop training for healthcare professionals (HCPs) whose disciplines are essential to the successful development of personalised medicine.
Therefore, what is required is a long-term approach to education, to facilitate all healthcare professionals in close contact with patients and their families to remain up-to-date with all current aspects of personalised medicine and its latest breakthroughs.
From a policymaking and regulatory perspective, European healthcare has reached a point where clear, harmonised rules and guidelines have to be in place.
But, none of the above can be successfully achieved without the involvement of all relevant stakeholders. These include patient groups, academics, researchers, IT professionals, industry representatives, health care professionals, HTA bodies from the EU 28, the EMA and, of course, policymakers and payers.
Policymakers at both EU and national level (European Commission, Parliament, Council and Member State health care payers) have a significant role to play in bringing about a Europe in which personalised medicine, in all its forms, can be integrated into national healthcare systems, via the sharing of data, cross-border collaboration in research projects, exchanging of best practices, and a seismic shift from a silo mentality, not only in the main cross-disciplinary fields but within single disciplines.
The EU cannot, as it stands, assume responsibility for all healthcare systems across Europe, but it can certainly recommend (as did the breakthrough Luxembourg Council Conclusions on Personalised Medicine) in the areas over which it does not have legal competence.
In order to make this possible, policymakers must thoroughly understand all the issues affecting access to personalised medicine. This would go a long way in opening the door for a new form of treatment that will bring better and longer lives to many patients across Europe’s borders.