Study provides recommendations on European Medicines Agency's communication on medicines

A recently published study produced by an independent expert offers recommendations to assist the European Medicines Agency's communication on the benefits and risks of medicines.

The report is a result of a year long project carried out by Dr Frederic Bouder and aims to provide evidence based input.

The study not only contains a detailed analysis of the expectations and attitudes of the different stakeholders of the agency regarding its communication on medicines but also draws up detailed recommendations for the agency such as the setting up of a risk communication advisory board.

The report further recommends the involvement of patients in communication activities, a review of the handling of its communication tools and to shape a strategic view on transparency.

The agency has already implemented some of the suggested recommendations.

Read the entire report here

The Diagnosis of Childhood Bipolar Disease has led to Catastrophic Consequences

There has been a call for the diagnosis of childhood bipolar disease to be axed from the Diagnostic and Statistical Manual of Mental Disorders (DSM) by one of its early editors. Experts argue that Bipolar disease emerges in early adolescence, no sooner. Jon Ronson reports in this month’s edition of the New Scientist on the controversial condition.

The DSM offers a checklist of symptoms to help diagnose psychiatric illnesses. The ever-expanding index of the manual is said to be an attribute of society’s perception of what is normal behaviour; further influence stemming from the pharmaceutical industry and patients groups.

Mr. Frances Allen, former editor of the DSM, is now critical of aspects of the diagnostic tool, stating that the inclusion of Childhood Bipolar disease was a mistake. Tragically, in the United States, a four year old child died after receiving a fatal dose of her prescribed medication to treat the disease. Her parents administered the bipolar medication whenever the child was “being annoying”.

HAI Europe advocates the rational use of medicines and will be addressing issues relating to conflicts on interest and psychiatric medicines at an open-seminar: Mad Medicine: Are conflicts of interest driving you crazy? It will be held in Cork, Ireland, on the 24^th of September, 2011. Please contact Lorraine at events@haieurope.org for further information.

DG Trade State of Play reveals EU's ambitions for IP protection in FTAs

The EU will not be changing its aggressive approach to IP protection in bilateral trade agreements, according to the updates that representatives from the European Commission gave at a State of Play meeting with civil society on June 27, 2011. Despite years of opposition and outrage by the global public health community, the EU continues to pursue high IP standards in trade deals with developing countries. Representatives from DG Trade stated that the EU will pursue ambitious IP standards in ongoing free trade agreement negotiations with India and Mercosur.

Apart from India and Mercosur, the EU is currently negotiating a trade deal with the Ukraine, where the need for medicines to treat such as HIV/AIDS is currently unmet. Aggressive IP protection introduced through the EU-Ukraine FTA could further restrict access to affordable ARVs, thwarting any initiative to slow the progression of this life threatening disease.

Evidence has shown that these ambitious IP provisions are detrimental to public health in countries with large poor populations because these policies have a negative impact on generic competition. Limited competition in the pharmaceutical market keeps prices high and hinders widespread access to medicines. In the Trading away access to medicines report (2009), HAI and Oxfam highlighted the problems of strict IP protection in the context of global health.

Even within the EU, an investigation into the EU pharmaceutical sector revealed a array of strategies used by companies to prolong the market dominance of their product, resulting in high prices for consumer and health care systems. (See HAI Europe response)