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In June, the US Supreme Court issued its opinion in the Myriad case (Association for Molecular Pathology v. Myriad Genetics Inc.).  The Supreme Court had been asked a seemingly simple question: “Are human genes patentable?”, and concluded that naturally occurring gene sequences are no longer patentable in the US.  In Europe, isolated gene sequences are still patentable, under certain conditions.  However, the differences between the two legal regimes are not as stark as might initially appear, and the practical effect for the diagnostics industry is complex.

It has been my privilege to serve as Executive Producer of Lab Tests Online for the last twelve years, overseeing its launch in the United States and expansion into 16 other countries. Of course, to say I “oversaw” the launch does not quite capture the roll-up-the-sleeves intensity of those early days in 2001 when I and then-intern Ellen O’Connell worked sometimes through the night and in collaboration with our Editorial Review Board to build and develop all that became the foundation of Lab Tests Online. In those first two years, the pace was unrelenting as we continued to develop, learn, and re-develop various aspects of the site, steadily improving the content and laying the groundwork for a model that would dramatically alter the scope of our work in a few short years.

My background in women’s rights has driven me to look into how my current field of work has taken issues which affect women into account. So as an EDMA Communications Intern, I decided to dive into the field of in vitro diagnostics (IVDs) to identify whether the makers of IVDs have played a role in empowering women.  Here’s what my investigation revealed…

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.

Many times I’ve found myself in situations where I had to explain that indeed in vitro diagnostics (IVDs) are to all extent medical devices but that, in practice, the subject we happened to be discussing would not entirely (or at all) be applicable to IVDs.
It was always a case of: “…yes, yes.. BUT”…
If there is one message you take away from this post, let it be… IVDs have very different risk sets associated to them: no direct contact with patient, value of the medical data they deliver and that they provide no treatment.

If there is one thing that the medical devices industry agrees on it is that the new proposals for medical devices and IVD regulations are welcome and necessary evolution of regulation. What the industry also agrees on is that although it generally supports the new proposals, it is not certain at all that the proposed scrutiny procedure will achieve the intended goals.

As an activist for maternal health rights in Romania and the Head of the White Cross Foundation for Maternity Healthcare Services, increasing health literacy and access to healthcare for as many Romanian mothers as possible is extremely instrumental to me. It is important that they understand the role and significance of prenatal tests. Though we [my organisation] had already been directing women to Lab Tests Online as part of an effort to help them better understand the role and importance of these tests, we relied on the languages that were available – English, French or German (as most educated women in Romanian are fluent in at least one of these languages), Hungarian (as Romania has quite a large Hungarian-speaking minority), Italian and Spanish (spoken by many low-income Romanian women who engaged in seasonal work in Spain and Italy). Unfortunately, the great service Lab Tests Online sites provide was not available in Romanian, or at least so was the case until the launch of the country’s own site in November 2012 through the noteworthy efforts of the Romanian Association of Medical Products Providers.

Advances in in vitro HIV/AIDS diagnostics, combined with the development of highly effective antiretroviral (ARV) drugs, have significantly reduced the transmission of HIV from mother to baby and greatly improved health outcomes for mothers living with HIV.  Simple and inexpensive tests screen for HIV within minutes, and point of care CD4 testing enables doctors to closely monitor a patient’s immune system to prescribe an effective combination of ARVs to keep mothers healthy during and after their pregnancy and their babies HIV-free.  As a result, new pediatric HIV infections have nearly halved in the last eight years and the number of deaths each year attributed to AIDS-related causes dropped 24% since the peak in 2005, to approximately 1.7 million in 2011.

The European Commission’s proposal to revise the medical device legal framework is a welcome step towards strengthening and improving the EU regulatory system. Recognised globally as being the fastest in providing life-saving technologies to patients without compromising safety, this thorough overhaul of the regulatory system seems to be mostly in line with Europe and President Barroso’s stated policy of ‘Smart Regulation’: ensuring the quality and relevance of EU legislation, which should benefit people and businesses.