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Regional Discount Agreements in Sweden: A Legal Minefield 

May, 2014 - Delphi - Sweden

Regional governments in Sweden are increasingly looking to leverage their purchasing power in order to secure discounts and rebates on the list prices of branded drugs.  However, as noted by Elizabeth Eklund, Partner at leading commercial law firm Delphi, such agreements risk running foul of both Swedish and European Union (EU) law.  Following her presentation at the recent Nordic Market & Patient Access Forum, staged by Next Level Pharma in Stockholm, Eoin Jennings spoke with her for PPR. 


MARKET ACCESS CHALLENGES IN SWEDEN


Eklund began by briefly outlining the challenges facing manufacturers seeking access to reimbursement in Sweden. “Manufacturers seeking to obtain reimbursement must apply to the Dental and Pharmaceutical Benefits Agency (TLV – see Box 1). The TLV makes decisions on both the drug’s price, and on whether the product should be reimbursed,” she noted.


“Getting the ‘right’ price, therefore, is key,” she advised, “but this can be very difficult to achieve, since it is not just a question for the national market in Sweden. Indeed, prices in Sweden are referenced by a number of other European countries, and manufacturers also have to be aware of the challenges posed by parallel trade.


“If reimbursement is not approved, there remains the possibility of negotiating discount agreements with the New Drug Therapies Group (see Box 1). This has particularly been the case for new cancer drugs, which tend to be very expensive, and where the TLV has tended to be quite restrictive in terms of the value attached to these products.


Please click on the link below for full article.
http://www.delphi.se/$-1/file/artiklar/2014/140505-2nd-annual-nordic-market-patient-access-forum.pdf


Footnotes:




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