NAFTA ne­go­ti­a­tions may threaten phar­ma­care

Sherbrooke Record - - EDITORIAL - By Joel Lexchin Pro­fes­sor Emer­i­tus of Health Pol­icy and Man­age­ment, York Univer­sity, Emer­gency Physi­cian at Univer­sity Health Net­work, As­so­ci­ate Pro­fes­sor of Fam­ily and Com­mu­nity Medicine, Univer­sity of Toronto

Around 91 per cent of Cana­di­ans want a na­tional phar­ma­care plan, ac­cord­ing to a re­cent na­tional poll, so they don’t have to choose be­tween buy­ing gro­ceries or pay­ing for drugs to keep them healthy.

The same pub­lic opin­ion sur­vey has also found that pre­scrip­tion drug ac­cess and af­ford­abil­ity are is­sues for al­most 25 per cent of Cana­dian house­holds.

But de­pend­ing on what hap­pens with the ongoing NAFTA rene­go­ti­a­tions, the cost of such a phar­ma­care plan could go up, pos­si­bly dra­mat­i­cally.

This has to do with some­thing called in­tel­lec­tual prop­erty rights (IPRS). Usu­ally when talk turns to IPRS peo­ple think about patents. But there’s also some­thing called data pro­tec­tion.

The data that’s be­ing pro­tected is in­for­ma­tion about the ef­fec­tive­ness and safety of drugs that comes out of the clin­i­cal tri­als that brand-name drug com­pa­nies do when they want ap­proval to mar­ket a new drug.

Generic drugs es­sen­tial to phar­ma­care

The data is the pri­vate prop­erty of the brand-name com­pa­nies and can’t be used by any­one else, in­clud­ing generic com­pa­nies, for a pe­riod of time.

It would be very costly for generic com­pa­nies to do the orig­i­nal test­ing all over again, and it would also be un­eth­i­cal be­cause the re­sults of the tri­als are al­ready known. So generic com­pa­nies use the data once it’s no longer pro­tected.

Data pro­tec­tion is not a sexy topic, but it’s im­por­tant in de­ter­min­ing how quickly some low-cost gener­ics can reach the mar­ket. The pres­ence of gener­ics keeps pub­lic drug plans af­ford­able and will be es­sen­tial for any phar­ma­care plan.

Right now, seven out of ev­ery 10 pre­scrip­tions are filled with generic drugs, but pay­ing for gener­ics only uses up 21 cents out of ev­ery dol­lar that is spent on pre­scrip­tion drugs in Canada. A generic pre­scrip­tion is about one-third the price of a brand-name one.

Patents al­ready mean that brand­name drugs are on the Cana­dian mar­ket for more than 12 years without any com­pe­ti­tion. When patents run out, generic drugs can be sold, but some­times patents ex­pire be­fore the data pro­tec­tion pe­riod is up. Un­til the data pro­tec­tion pe­riod ends, there can’t be any gener­ics. What’s more, un­like patents, data pro­tec­tion can’t be chal­lenged in the courts.

Ten years of data ex­clu­siv­ity

Canada used to of­fer five years of data pro­tec­tion but both the lobby group for Big Pharma here and in the United States found that time pe­riod un­ac­cept­able.

In the end, as a re­sult of the lob­by­ing ef­forts by the phar­ma­ceu­ti­cal in­dus­try, Canada amended its reg­u­la­tions on data pro­tec­tion to al­low for eight years of data ex­clu­siv­ity. An ex­tra six months is pos­si­ble if the com­pany mar­ket­ing the drug is able to de­ter­mine that chil­dren need the drug.

Now comes word that in the bi­lat­eral United States-mex­ico NAFTA talks, there was an agree­ment that bi­o­log­ics will have 10 years of data ex­clu­siv­ity.

Bi­o­log­ics are in­jectable drugs that are used to treat var­i­ous forms of arthri­tis, Crohn’s disease and ul­cer­a­tive col­i­tis (in­flam­ma­tory bowel con­di­tions), mul­ti­ple sclero­sis and a va­ri­ety of other dis­eases.

Bi­o­log­ics can be very ef­fec­tive but they come with a high cost.

Big money spent on bi­o­log­ics

Ac­cord­ing to the lat­est re­port from the Patented Medicine Prices Re­view Board, a fed­eral agency that sets a max­i­mum in­tro­duc­tory price for new patented medicines, bi­o­log­ics ac­counted for seven of the top 10 patented drugs in Canada based on the amount spent in 2017.

No. 1 on the list is in­flix­imab (Rem­i­cade), used in the treat­ment of rheuma­toid arthri­tis and ul­cer­a­tive col­i­tis, among other ill­nesses. The av­er­age an­nual cost for a course of treat­ment with Rem­i­cade is close to $29,000 and, in to­tal, just shy of $1 bil­lion was spent on this one medicine alone in 2017 by pa­tients, pro­vin­cial drug plans and pri­vate in­sur­ers.

No. 6 on the list is etan­er­cept (En­brel) also used for var­i­ous forms of arthri­tis. The av­er­age an­nual cost for En­brel is $13,600.

But for some of these bi­o­log­ics, there is the rough equiv­a­lent of a generic, known as a “sub­se­quent en­try bi­o­logic (SEB).” Whereas a sin­gle dose of En­brel costs $406, a sin­gle dose of its SEB is only $255 — more than a third less expensive.

If the U.S. pushes Canada to ac­cept the same data pro­tec­tion pe­riod that Mex­ico did, then data pro­tec­tion here goes up by an­other 1.5 to two years. Then we might very well be spend­ing a lot more on some bi­o­log­ics, be­cause the SEBS will be de­layed.

If we want a na­tional phar­ma­care sys­tem, then we need to make sure that our ne­go­tia­tors don’t give in to any Amer­i­can de­mands about med­i­cal data pro­tec­tion.

In 2015-2018, Joel Lexchin was a paid con­sul­tant on three projects: one look­ing at in­di­ca­tion-based pre­scrib­ing (United States Agency for Health­care Re­search and Qual­ity), a sec­ond to de­velop prin­ci­ples for con­ser­va­tive di­ag­no­sis (Gor­don and Betty Moore Foun­da­tion) and a third de­cid­ing what drugs should be pro­vided free of charge by gen­eral prac­ti­tion­ers (Gov­ern­ment of Canada, On­tario Sup­port­ing Pa­tient Ori­ented Re­search Sup­port Unit and the St Michael’s Hospi­tal Foun­da­tion). He also re­ceived pay­ment for be­ing on a panel that dis­cussed a phar­ma­care plan for Canada (Cana­dian In­sti­tute, a for-profit or­ga­ni­za­tion). He is cur­rently a mem­ber of re­search groups that are re­ceiv­ing money from the Cana­dian In­sti­tutes of Health Re­search and the Aus­tralian Na­tional Health and Med­i­cal Re­search Coun­cil. He is mem­ber of the Foun­da­tion Board of Health Ac­tion In­ter­na­tional and the Board of Cana­dian Doc­tors for Medi­care.

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