Amendment to the Act on Medicinal Products – Another Step towards the Digitisation of the Health Service and a New Obligation to Report the Prices of Medicinal Products
The Chamber of Deputies is currently debating, as Parliamentary Print No. 302, Amendment to Act No. 378/2007 Coll., on Medicinal Products and Amendments to Some Relating Acts, as amended (the “Medicinal Products Act”). On 9 May 2019, the Medicinal Products Act passed the second reading in the Chamber of Deputies, with proposed amendments sent to deputies on 10 May 2019. The third reading of the amendment is currently scheduled for the 30th Chamber of Deputies’ session, ie on 28 May 2019.
Patient’s Pharmaceutical Record
Since January 2018, physicians have been obliged (with the exception of specific cases) to issue prescriptions in the electronic form. Nevertheless, the existing wording of the Medicinal Products Act makes it impossible to further use the information on the medicinal products prescribed and dispensed in providing health services to the patient. However, this information may, in fact, be of crucial importance for the attending physician as well as the pharmacist dispensing the prescribed medicinal products so that possible contraindications of individual prescribed pharmaceuticals can be identified in time and the patient’s safety ensured.
Thanks to the pharmaceutical record, physicians and pharmacists should be provided, in the Central Repository of Electronic Prescriptions, with access to information not only about all prescribed medicinal products, but also about those actually dispensed. Physicians (registering or attending to the patient, or emergency service physicians) will have access to pharmacotherapy information through the pharmaceutical record only in relation to the provision of health services. Similar will apply to pharmacists, who will be able to consult the pharmaceutical record in dispensing a medicinal product (based on a valid and as yet fully unutilised e-prescription) or during personal consultations with the patient (by entering the number of the patient’s identity card or passport in the eRecept system). Restrictions to the range of authorised persons should prevent the threat of the data contained in the pharmaceutical record being leaked or abused.
The Patient Need not Agree
Nevertheless, the patient will be able to express their opposition to having their record accessed at any time (referred to as the “opt-out”). The patient may revoke their opposition at any time (ie, make it possible to have their pharmaceutical record accessed within the boundaries of law), or only give their consent to having their record accessed to specific physicians or pharmacists (referred to as the “selective consent”).
Physicians and pharmacists will be able to view the information about the patient’s medication stored in the eRecept system under the above-described conditions for a period of up to one year from the date on which the relevant record was created. However, in our view, it would be appropriate if, at least under certain conditions, the physician had a comprehensive knowledge of the patient’s entire pharmacological history.
Obligation to Report Information about the Price of the Medicinal Product
Furthermore, the amendment extends the reporting duty of the holders of marketing authorisation under Section 33 of the Medicinal Products Act. At present, marketing authorisation holders are already obliged to report, to the State Institute for Drug Control (the “Institute”), among others, information on the volume of the supplies of medicinal products introduced on the Czech market, including the identification of medicinal products and information as to whether they were supplied to a distributor or a pharmacy. Marketing authorisation holders will also be newly obliged to inform the Institute of the price of the medicinal product in the report.
By analogy, the amendment also revises Sections 77 and 82 of the Medicinal Products Act, which stipulate the scope of compulsory reports in respect of distributors and pharmacies. These entities will also be newly obliged as part of the reporting duty to inform the Institute of the prices of medicinal products. In respect of distributors, this will apply to the price for which the medicinal product was supplied to another distributor in the distribution chain or pharmacy. In respect of pharmacies, this will apply to the prices for which the medicinal product was dispensed.
The sanction for violating the reporting duty, which also newly includes the duty to report information on the prices of medicinal products, may amount to a maximum of CZK 20 million in respect of the violation by a marketing authorisation holder, and a maximum of CZK 5 million in respect of the violation by a distributor.
We have discussed the amendment in greater detail in the following article: https://www.epravo.cz/top/clanky/novelizace-zakona-o-lecivech-dalsi-krok-k-elektronizaci-zdravotnictvi-a-nenapadna-lec-zasadni-nova-povinnost-hlasit-ceny-lecivych-pripravku-109220.html
The amended act is likely to become effective on the first day of the second calendar month following the promulgation date, ie on 1 July 2019 at the earliest (the effective date is also subject to proposed amendments, both on the part of the Constitutional Committee and deputies).
A series of major amendments have been proposed in respect of the bill:
- Two of the proposed amendments include a change in the system of the patient’s presumed agreement (opt-out) to the opt-in system. Therefore, the concept is quite the reverse, whereby it would only be possible to access the information in the patient’s record based on the patient’s previous consent, namely owing to the sensitivity of medication data and indirectly the patient’s health condition. Another major argument in favour of the opt-in concept is the association of certain chronic conditions with a high degree of social stigmatisation. Patient organisations repeatedly record breaches of the confidentiality obligation in respect of these conditions, which often leads to the patient’s further social ostracism.
- Another amendment has been proposed by Patrik Nacher, who proposes that the regulation governing the mail order dispensation of prescription-only medicinal products be revised with effect from January 2021. Therefore, it should newly be possible to dispense not only over-the-counter (so called OTC) medicine, but also prescription-only medicine.
- Based on the amendment proposed by a group of deputies headed by Petr Pávek, Section 77 (1) (h) of the Medicinal Products Act, the purpose of which is to ensure the availability of medicinal products for patients, should be revised. At present, the provision stipulates that distributors must ensure the delivery of a medicinal product following the pharmacy’s request no later than within two working days, with the pharmacy being able to contact any distributor regardless of whether the distributor trades with the medicinal product or not. Subsequently, marketing authorisation holders are obliged to supply the medicinal product to the distributor in the volume corresponding to the size of its market share. The amendment restricts the distributor’s right to call on the marketing authorisation holder to supply the medicinal product if the availability is not ensured by the marketing authorisation holder otherwise. Subsequently, the distributor is obliged to supply the medicinal products supplied to it by the marketing authorisation holder based on a call only to a pharmacy (or a physician in the event of vaccines). The amendment additionally abolishes considering distributors’ market shares, also in view of non-compliance with competition law mentioned multiple times in the past.
- The affected provision is also addressed by another amendment, this time proposed by the government, which, besides the abolition of the section relating to market shares, proposes that the obligation to supply requested medicinal products within two days should only apply to the distributors that will voluntarily assume the obligation in assuming the public service obligation based on a written statement to the marketing authorisation holder. Furthermore, the amendment introduces a protected distribution system as part of which the distributor, that has voluntarily assumed the duty, is obliged to maintain stocks of inventory in such amounts as to be able to supply the necessary medicinal products to a pharmacy within two working days.
Deloitte’s Note: The above-outlined proposed amendments relating to the obligatory system of supplies merely confirm the shortcomings of the existing legislation which the experts from among the public have pointed out since the very beginning of its existence. Therefore, a systemic change may be expected in respect of the emergency supply system in the near future.
- According to the amendment proposed by deputy Kamal Farhan, the Institute should newly be authorised to also provide information relating to the certificates that it issues under Section 81a (1) of the Medicinal Products Act for access to the eRecept system to other bodies within the departmental scope of authority of the Ministry of Health (including the Czech Social Security Administration for the purposes of verifying the identity of attending physicians in the eNeschopenka or “e-Sick Leave” system) that will also be able to use the certificate to access and use the services and systems established or managed by departmental organisations.
- Furthermore, the amendment proposed by Věra Adámková recommends revising the regulation on food supplement advertising, which will have to contain an explicit and legible caution to consult the consumption of food supplements with a physician or a pharmacist. At the same time, the amendment should abolish the liability of advertising agents for the contents of advertising, given that they do not have the necessary specialised qualifications as opposed to ordering parties and processors.
- The amendment proposed by deputy Tomáš Vymazal addresses the price regulation of cannabis-containing medicinal products. The objective of the proposal is for individually prepared medicinal products containing cannabis to be fully covered for Czech patients, regardless of the unavailability, if applicable, of Czech cannabis and the necessity to procure cannabis through cross-border supplies. In this context, it is proposed that the method of determining the maximum price of the medicinal products be revised; however, from the perspective of pricing and coverage, this seems to be non-systemic.
The article is part of dReport – May 2019, Legal news.