Polish pharmaceuticals market Clinic Pharma - our expert scientists and researches in Poland assist you through pharmaceuticals and medical aspects of drugs registration in Poland: pre-registration and post-registration including medical, pharmaceutical aspects of medicinal products and medical translation into polish.

Expert Voice

During last two months there is a growing pressure on the budget to increase the GNP share for the health care. All the parties present at several meetings, e.g. "Koalicja dla Zdrowia", "Reimbursement", "Rynek Zdrowia" and others argue that this share should be increased by 2%. Ministry declares (this is not a new declaration, some may thing about déja vu phenomenon)

• that all ineffective drugs will be removed from the reimbursement list (almost each administration "cleaned" the list in the past),
• that every 3 months the list will be renewed (another déja vu)
• that new law will be passed later this year covering all rules of reimbursement

Whatever Ministry says it is welcomed however there are some doubts about pouring money into inefficient system. Perhaps new law and clear criteria for reimbursement should proceed any increase in health care money.

The Ministry declares to fight with "me-too" drugs, however these drugs lower the price of innovator and form the basis for so-called "limit" price. Perhaps the Ministry wishes to remove me-too drugs because of competition with generics, generics however are not in all categories of drugs, especially in category of the most expensive. With the absence of generics in given category the presence of me-too lowers the overall price.

Another interesting initiative is the refusal of National Health Funds (NHF) to reimburse drugs used off label. Indeed, in several area of pharmacology the drugs are very often used that way, e.g. pediatrics and oncology. In the States drugs may be used off label but when there is a case in the court the physician must defend himself such use on the basis of the literature. The problem is real as in the course of drug development (usually in phase 3 trials) the efficacy of the drug is tested for specific indications. In other words, the use off label would indicate that there is no proof of drug efficacy in off label use. However, most of the drugs used in children were never tested for such use. That is why producers often admit in SmPC that the given drug was not tested in children. In fact it is a new move, supported by EMEA, that drugs intended for kids should be tested in children. In oncology drugs have now abbreviated registration procedure, some are conditionally registered (all to accelerate new discoveries) so the off label use may increase. Many physicians believe - not without arguments - that off label use may lead to the discovery of a new indication. So it is classical 22 catch: there is no good solution and to ban the use off label (this will be the result of denying reimbursement) or to accept it totally are equally erroneous.

Clinic Pharma can be of help in the following fields:

• Registration of medicinal products;
• Clinical studies, phase I - IV, including non-clinical;
• Piggy-back trials;
• Pharmacoeconomic analyses (including reimbursement application);
• Training of employees;
• Scientific matters

We were established in 1998 under the name NOBEF, Independent Centre for Pharmaceutical and Economical Research that was changed this year to Clinic Pharma.

Our expert scientists, academicians and researches through Poland can assist you through all phases of non-clinical, early clinical, pre-registration and post-registration trials including medical, pharmaceutical and pharmacoeconomic aspects of medicinal products.

Even if you know how to do it, we can always improve it. In the world of scientific excellence even small improvements can add value to your project.

Our assistance will go from very complicated regulatory affairs related to registration of drugs (medicinal products) or effectiveness studies of your product in clinical trials and/or pharmacoeconomics to apparently simple translations of Summary of Product Characteristic and Patient Leaflet.

The ideas mentioned above are extremely important at the stage of planning. Once the project is well-planned the chances for success are high.

Success means value: excellent plan is a success as well as each step, even the smallest one, on the way to the big goal. We think meticulously on each move - this is how we build and how we consider value.

Achieving a goal is of paramount importance. It does not matter whether you are starting your business or "you are old" in the business and you know how to do it. When you are starting you need a success to survive, when you are "old" you cannot afford a failure.

Throughout the life of your medicinal product, especially at its delivery, and to help its survival our service is of real value. Try us to know how profitable could be our assistance.