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In 2008 Eucomed published its revised Code of Ethical Business Practice. We’re six years on now and we’re thinking about writing a new one. Why? Because so much has changed in the world of medtech compliance.

In Europe, health data are considered so sensitive that processing them is generally prohibited in the EU, unless that processing follows specific guidelines. For example, the prohibition does not apply when sharing data is essential to providing healthcare, where those data are handled by a Healthcare Professional (HCP) subject under national law and subject to professional secrecy laws. With the rapid growth in diversity of medical technologies though, more and more medtech companies are processing health data on behalf of HCPs. 

Imagine walking for most of the day to get to the health center nearest your community, carrying your young child who is very ill. When you arrive, the doctor takes a sample from your child to perform a diagnostic test. You then learn that it will take a month or more to receive the results, as only a specialised laboratory can perform the necessary test to obtain a diagnosis. This sort of unnecessary delay can be the difference between life and death. It is still, nevertheless, the reality in many countries, especially in limited resource settings where diagnostic testing is centralised, and most patients live far from testing sites.

Europe’s medical device industry has always agreed that Europe’s regulatory system for devices needs to be improved and has put forward various proposals to achieve this. In the wake of a case of fraud like the PIP breast implant incident, it is clear that we need a safer system that makes sure Europe’s patients continue to have timely access to the latest life-saving and life-enhancing medical technologies.

Value creation capabilities based solely on R&D investment are not generating as much growth as they used to. According to PwC’s “Operating performance in the Medtech industry: Trends and imperatives” report, which studied the performance of 56 global medtech companies, the impact of R&D on revenue growth declined at an average annual rate of 10% and the return on invested capital declined at a rate of 2% between 2005 and 2011. The impact on growth is evident by revenue growth rates declining at a rate of approximately 12% per year.

With its Contract for a Healthy Future,  the medical technology industry acknowledges its role and responsibility in maintaining high-quality, affordable healthcare in Europe despite an ageing population and constrained budgets. This industry commitment offers the much needed solutions to prove that innovation is not a cost driver but a facilitator for driving healthcare quality and efficiency in the future.  From personalized medicine to disease monitoring, the role of the diagnostics industry will be crucial in managing healthcare spending.

Being a patient myself, I am keenly aware of the importance of having access to innovative technologies to support my lifestyle and foster improved health and well-being.  And, as a former policymaker in both the UK and the EU, I also understand the enormous responsibility of the healthcare system in determining which of the newest medical technologies are the safest and most effective for patients in each health constituency.

It is difficult to remedy these demands – those of patients, health systems and policymakers. 

World Health Day approaching us on April 7^th is meant to raise awareness on the endless host of hurdles that undermines our health and therefore, our quality of life. Public health is about making sure that the external factors that determine our health are governed by policies that have people’s well-being at the very heart of their mandate. EPHA, Europe’s leading NGO advocating for better health, is committed to that very principle.

This year marks EPHA’s 20^th anniversary in advocating EU and European policy-makers on public health. Bringing today’s leaders to focus on people’s health is not an easy task. The medical devices and in vitro diagnostics files appropriately represent the juggling effort that advocating for public health usually turns out to be.

Health First Europe has always believed that by bringing together all health stakeholders, solutions for challenges in healthcare can be found that benefit all patients.  In 2012, we continued in our conviction that together we could better protect patients and improve access to treatment by working with the EU institutions and other EU health stakeholders. This past year, our work on patient safety and health technology assessment (HTA) produced concrete recommendations for policymakers on how the EU can support the improvement and delivery of care for patients.
In 2013, we will not only further our work on patient safety and quality of care, but also expand our issue engagement to look beyond safety and access, to patient empowerment, health literacy and community care.  Encouraging patients to be informed about their care is of great importance as health systems adapt and change to the meet the needs of an ageing population as well as shortages of healthcare professionals and tighter budgets for delivering care.