Katarzyna Miaskowska-Daszkiewicz Ph.D. Chancellery of the Sejm, Warszaw, Poland John Paul II Catholic University of Lublin European prescription and the availability of medicinal products

Directive 2011/24/EU From the normative content of the right to health should interpret the right to access to medicines ‘Healthcare’ means health services provided by health professionals to patients to assess, maintain or restore their state of health, including the prescription, dispensation and provision of medicinal produc ts and medical devices (Art. 3.a) ‘Prescription’ means a prescription for a medicinal product or for a medical device issued by a membe r of a regulated health profession within the meaning of Article 3(1)(a) of Directive 2005/36/EC who i s legally entitled to do so in the Member State in which the prescription is issued (Art. 3.k) Right to health

The reasons for the lack of availability of medicines 1) low price in one national market for a new product can lead manufacturers to refrain from launching the product in other markets 2) some MS are unable to meet the high cost of some treatments - the costly new treatments for cancer or the “orphan” treatments for rare diseases 3) parallel trade might potentially lead to shortages in exporting MS 4) price capping policies - discourage entrepreneurs to market the drug in a given market

Polish example The diverse social and economic factors in each Member States affect the scope of implementation of access to reimbursed medicines (in the scope of right to access to health care). Each country within its own budget and legal challenges is trying to fulfill its assig ned tasks in said respect. One way of execution of mentioned tasks is to introduc e a system of reimbursement, which guarantees quantitatively and qualitatively wi dest access to the low prices medicines. The phenomena which has its source on Polish market but finally crossing border s of other EU Member States, shows that attempts to provide an optimized mech anism guaranteeing an access to refunded low prices medicines in the confrontati on with the rules governing the EU Single Market can lead to undesirable results.

Legal facts enter into force the Act on the Reimbursement of Medicines, Foodstuff Inte nded for Particular Nutritional Uses and Medical Devices, May 22, 2011 Main assuptions: prices and margins for reimbursed medicines are fixed, prices are negotiated with producers Desire effects: 2014 – the prices on the medicinal products are the lowest in EU and steadily dec lining the average surcharge for drug refunded less than 10 zł (2,5 EUR)

Availability in figures July 2012 : reimbursed medicines – 3195 therapeutical programmes chemiotherapy – 350 May 2015: reimbursed medicines – 3844 therapeutical programmes chemiotherapy – 482

Undesire effects Paralel export – the practice of wholesalers exporting products originally importe d to a particular country to another country, usually where they can obtain a higher price - free movement of goods - Art TFEU The value of exported medicines: 2010 – 800 mln PLN (200 mln EUR) 2014 – 3 billion PLN (0,75 billion EUR)

still absent in Polish market……

Art. 11 Directive 2011/24/EU – ‘’medical recognition’’ If a medicinal product is authorised to be marketed on their territory, in accordance with Directive 2001 /83/EC or Regulation (EC) No 726/2004, Member States shall ensure that prescriptions issued for suc h a product in another Member State for a named patient can be dispensed on their territory in compli ance with their national legislation in force, and that any restrictions on recognition of individual prescr iptions are prohibited unless such restrictions are: b) limited to what is necessary and proportionate to safeguard human health, and non-discriminatory; or (b) based on legitimate and justified doubts about the auth enticity, content or comprehensibility of an individual prescription Cross-border prescription as a cure

Polish legal framework Art. 45 of Act on professions of physician and dentist (1996) Doctor may prescribe medications, foods for particular nutritional uses, which are authorised in the Republic of Poland under the terms of separate regulations (Art. 45.1) In justified cases, the doctor may prescribe medicines authorized in other countries, with simultaneous detailed reasons in the medical records (Art. 45.3) The doctor has a duty to exercise the profession, as indicated by current medical knowledge available to him the methods and means of prevention, diagnosis and treatment of diseases, according to the ru les of professional ethics and with due diligence (Art. 4)

Weak points 1.Method of payment for drugs abroad 2.Request of a patient 3.Drug substitution - liability of the physician

Method of payment for drugs abroad „Cross-border prescription can be realized only with full payment - regardless of t he powers conferred patient in Poland. After returning the patient can apply for reimbursement to the level of reimbursement by. Art. Paragraph 42c. 1 p oint 3 or 4 of the Act on health care benefits”. the method of payment implies that we must first have sufficient funds to purchas e the medicinal product abroad

request of a patient The doctor can issue the prescription, only at the request of a patient who is going to implement it in other than Polish EU Member State. assumption - the patient is aware of this possibility

Drug substitution regulation of Minister of Health on medical prescriptions (2012) – lack of possibility to take advantage of claim "not replace" on the cross-border prescription„cross-border prescription contains the following data” a reservation relating the need to issue only a particular drug to a patient, foodstu ff for particular nutritional uses a medical device by posting an entry "not replace” under Polish law, the doctor is responsible for pharmacotherapy patient may receive abroad a replacement, for which effect the doctor in Poland will also be responsible it may discourage doctors

a paradigm shift realization of prescription by the way tourism drug tourism

Thank you for your attention! dr Katarzyna Miaskowska-Daszkiewicz