ORGANIZATION: Ministry of Health in Poland (MoH), Agency for Health Technology Assessment in Poland (AHTAPol) PROBLEM OR ISSUE ADDRESSED: The European Commission (EC) has pointed out certain areas for improvement in the process of reimbursement decision - making in Poland, especially in the field of transparency and compatibility with Directive 89/105/EEC and EC jurisprudence as well as long delays in making decisions. Moreover the pharmaceutical industry complained about too long and unclear decision making process. It should have been improved in areas such as: setting deadlines for taking decisions; objective and verifiable criteria; clear and adequate information of the decision to applicants; inclusion of expert opinions in the process of conducting decisions. GOALS: To establish decision – making system, transparent and clear for all stakeholders and in line with the Transparency Directive. OUTCOMES ITEMS USED IN THE DECISION: In the decisions–making process on drug reimbursement Poland uses outcomes concerning effectiveness and safety, cost-effectiveness, budget impact analyses, health priorities and price negotiations. IMPLEMENTATION STRATEGY: To solve the above-mentioned problems an EU Twinning Project between Poland and France was signed and took place between October 2006 and April 2008. The European experts analyzed the Polish reimbursement system and gave recommendations on how to improve it. During the Project employees of MoH and AHTAPol were sent on study trips and internships to gain knowledge about other Europeans systems and work in different institutions involved. Moreover the several workshops and conferences took place during and after the EU Project with all involved stakeholders to set up the best available drug reimbursement decision making process. During the workshops we used recommendations done by EU experts as well as other countries experiences. The workshops were divided into 3 groups based on their tasks: to identify reimbursement and pricing criteria; to divide responsibilities between main actors and to define role of different stakeholders involved in the process. The first seminar aimed at creating the momentum in which the necessary political decisions could be made. During this seminar three Vice-Ministers of the Ministry of Health confirmed that a new comprehensive Bill on reimbursement decisions would encompass the entire procedure of decision-making, from the moment of first application until the final decision made by the Ministry. RESULTS: As a result of the workshops the detailed process of making reimbursement decisions has been specified and the criteria for reimbursement and pricing are being defined. Bill regulating the reimbursement system in Poland is being prepared and will be implemented into polish legal system in January 2009. The Bill regulates the tasks of HTA Agency, its Consultative Council, which makes recommendations, and MoH in the process. It names the health priorities taken into account while giving recommendations, lists all the documents and analyses required in the reimbursement application. A separate Regulation will be prepared with the template of the reimbursement application and description of properly write analyses based on polish HTA guideline. The process of including (or excluding) drug to the reimbursement list is divided on the steps taking place in different institutions. The separate tracks are set for innovative drugs and for generics. The specialized institutions are responsible for each step: clinical effectiveness, safety and cost effectiveness is assessed in AHTAPol, formal and legal requirements in MoH, price negotiations by special Negotiations Committee and final recommendations to Minister is made by Reimbursement Committee which advice the Minister of Health. The documents prepared in each step of the process will be transparent and available for all stakeholders except price negotiations which are confidential and results are known only to the Ministry and the company involved. The whole process described above will result in a clear and transparent system of drug reimbursement in Poland, which will be implemented into the Polish legal system in 2009. That was big and important project, which improved cooperation between policy makers and industry, between international HTA experts and between Poland, France, the EC and other Member States. LESSONS LEARNED: For creating a new or improving existing reimbursement decision making process experience of other countries is indispensible. Changes in the process should be transparent, understandable for all stakeholders and if possible consulted with all parties involved; policy makers, EC, industry, health professionals and patients associations.