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What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?
A market authorisation holder is required to implement a pharmacovigilance system for monitoring the security of its product in accordance with the applicable EU regulation and directive. The Medical Products Agency conducts inspections to verify the compliance of implemented pharmacovigilance systems with applicable laws and regulations.
What data protection issues should be considered when conducting pharmacovigilance activities?
The EU General Data Protection Regulation (GDPR) applies to pharmacovigilance activities in Sweden. The application of the GDPR in pharmacovigilance activities raises specific challenges with regard to consent as it may be difficult to obtain consent from data subjects in most cases for the purpose of processing their personal data. Alternatively, the processing of sensitive personal data can be permitted if it is necessary in specific circumstances for reasons of public interest in the area of public health (eg, ensuring high standards of quality and the safety of healthcare and medicinal products or medical devices). Regarding clinical trials, the large-scale processing of sensitive personal data is subject to conducting a data protection impact assessment and designating a data protection officer.
Pricing and reimbursement
What is the structure for state reimbursement of medicinal product costs?
Sweden has adopted a value-based pricing reimbursement model for medicinal products. The TLV decides on the prescription medicinal products for out-patient care to be included in the reimbursement system. There are three main criteria which must be fulfilled if a medicinal product (including generic products and biosimilars) should be reimbursed:
- the human value principle, which underlines the respect for equality of all human beings and the integrity of every individual (ie, prohibiting discrimination against people on the grounds of sex, race or age, among other things, when making decisions on reimbursement);
- the need and solidarity principle, which provides that those in greatest need take precedence when it comes to reimbursing medicinal products; and
- the cost-effectiveness principle (ie, that the cost for using a medicine should be reasonable from a medical, humanitarian and social-economic perspective).
An application of a specific product to take part of the reimbursement system must be made to the TLV. The TLV then decides whether to include the product in the reimbursement system and consequently the price of the product.
Are there rules governing the pricing of medicinal products in your jurisdiction?
The Swedish Dental and Pharmaceutical Benefits Agency (TLV) sets the reimbursement price (eg, the sales price) for prescription pharmaceuticals that are subject to the cost-reduction systems (see “Reimbursement” below). The price set by the TLV is valid throughout Sweden. Superior cost-effectiveness in comparison to other products must be proved in order to obtain a listing under the pharmaceutical benefit scheme. Further, pharmacies are obliged to substitute prescription pharmaceuticals for the cheapest generic product on the market (the so-called ‘product of the period’ – established on a monthly basis by the TLV).
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