European Regulatory and Market Access Trends for Medical Devices

Representatives over 50 companies will meet in Opatija, Croatia to discuss the latest achievements of medical device companies and to define the right strategy, to develop the appropriate regulatory and markets access plans, and to find the way to execute them efficiently.

At the conference will be highlighted the major trends that are shaping the medical device industry and provide the guidance on how the medical device industry leaders can successfully navigate these trends.

At the conference spekers will benchmark the recent policy developments & changes in healthcare systems across major European markets to ensure that patients have better access to new medical devices

Croatia - Agreement on Ethical Advertising of Reimbursed Drugs

Due to the new Croatian Ordinance on pricing and reimbursement from this year , every MAH who wants to have its products on reimbursement list in Croatia has to sign the so called "Agreement on Ethical Advertising of Drugs". This Agreement is between MAH and HZZO (Croatian Institute for Health Insurance). I attached Croatian version for you info.

Basically, the Agreement strictly defines ways of advertising the products which are on the reimbursement lists toward healthcare professionals and possibility of giving certain presentation gifts to them (the max. value of such present can't be more than 150 €).

Second annual Conference on Pharmaceutical Risk-Sharing  & Value-based Pricing and Reimbursement Models

Bratislava, 15-16 th April 2010

Not being a specialist in the area of Risk-Sharing & Value-based Pricing this event was an excellent introduction for me. Meeting P&R experts from some of the most important pharma companies in the world as well as hearing their detailed presentations was a really good experience.

The event was splendidly organized by Next Level Pharma in Trend Hotel,Bratislava, SK, near the city centre, which was an excellent location. The overall impression was ruined only by a bad weather which did not allow a proper sightseeing of the city and disturbed air traffic which made problems to the return flight of most participants.

Enforcement of new pricing and reimbursement ordinance in Croatia

Croatian Institute for Health Insurance (HZZO) has informed all marketing authorization holders that 22nd August 2009 is deadline for adjustment of thier prices with "Low on Medicines" (Narodne Novine 71/07) and with new  "Ordinance about measures for determination of prices of medicines and ways for reporting about wholesale prices" (Narodne Novine no. 60/08).

According to new Ordinance price should be 65% of average (composite) wholesale prices from EU.