{"id":122173,"date":"2019-06-10T12:50:18","date_gmt":"2019-06-10T12:50:18","guid":{"rendered":"https:\/\/www.bnreport.com\/not-playing-nice-uk-drugs-gatekeeper-in-us-crosshairs\/"},"modified":"2019-06-10T12:50:18","modified_gmt":"2019-06-10T12:50:18","slug":"not-playing-nice-uk-drugs-gatekeeper-in-us-crosshairs","status":"publish","type":"post","link":"https:\/\/www.bnreport.com\/en\/not-playing-nice-uk-drugs-gatekeeper-in-us-crosshairs\/","title":{"rendered":"Not playing NICE: UK drugs gatekeeper in US crosshairs"},"content":{"rendered":"

LONDON \u2014 The U.S. wants Britain to buy more of its drugs after Brexit \u2014 but it also wants Britain to pay more.<\/p>\n

During Donald Trumps visit to London this week, he urged the U.K. to get moving with its plans to quit the European Union so it can forge a \u201cphenomenal\u201d trade deal with the U.S.<\/p>\n

As part of that deal, the U.S. could seek to dismantle one of the U.K.s most prized health system components \u2014 the value assessments undertaken on new medicines to keep costs down, and limit the amount paid out to drugmakers.<\/p>\n

With both Trump and U.S. Ambassador to the U.K. Woody Johnson saying health care will be a strong focus<\/a> in a future trade deal, filings to the U.S. trade department show American pharmaceutical companies want to chip away at the so-called health technology assessment done by the National Institute for Health and Care Excellence (NICE) as part of that agreement.<\/p>\n

Its a hefty demand that could stall any trade talks from the start, but if realized would have pricing implications for drugs worldwide.<\/p>\n

\nIn 2017, American biopharmaceutical exports to the U.K. were valued at over $3.6 billion while the U.S. imported $5.5 billion from Britain.\n<\/p><\/blockquote>\n

Medicines in the U.K. cost about a third of U.S. prices, and Trump has directed much of his \u201cforeign freeloaders\u201d rhetoric toward European states, arguing other countries should pay more for U.S. pharmaceutical research efforts.<\/p>\n

\u201cTheir biggest issue is with medicine prices,\u201d said David Henig, former trade negotiator for the U.K. government and director of the U.K. Trade Policy Project at the European Centre for International Political Economy (ECIPE).<\/p>\n

NICE, set up in 1999, has earned its reputation as the U.K. drugs gatekeeper precisely because of its impact on keeping costs down. The U.K. \u201cis not just a big buyer [of pharmaceuticals] in its own right, its also used as a reference price for perhaps up to 25 percent of global pharma sales,\u201d Henig said this week<\/a>.<\/p>\n

The gatekeepers work in measuring the value of new medicines would be considered by the U.S. as \u201ca technical barrier to trade,\u201d said Martin McKee, professor of European public health at the London School of Hygiene and Tropical Medicine. \u201cSo they would want to scrap it entirely.\u201d<\/p>\n

<\/p>\n

Capsules are seen on the production line | Gerard Julien\/AFP via Getty Images<\/p>\n

In a January submission<\/a> to the U.S. Trade Representative (USTR) on the U.K. deal, American drugs lobby PhRMA took aim at the process, referencing precedents in trade deals agreed with Mexico, Canada and South Korea on drug pricing.<\/p>\n

\u201cThey propose \u2026 an agreement by both parties to recognize a variety of value criteria; and that [health technology assessment] should not be the principle framework for assessing value,\u201d said Sam Lowe, senior research fellow at the Centre for European Reform.<\/p>\n

Asked about PhRMAs goals, a spokesperson referred to the submission, which said the trade deficit between the U.S. and U.K. is \u201cindicative of the significant need to negotiate a free and fair-trade agreement that eliminates non-tariff barriers and fosters greater exports to this important market.\u201d<\/p>\n

In 2017, American biopharmaceutical exports to the U.K. were valued at over $3.6 billion while the U.S. imported $5.5 billion from Britain.<\/p>\n

But Brits protectionism toward their health service and fear of the influence of American pharmaceutical companies will play into the politics<\/a> of any deal that makes the U.K. market appear friendly toward the U.S.<\/p>\n

\u201cIf I were to be a betting man, I would say that the U.S. would need to drop [drug pricing] as a substantive ask in order to get a deal over the line \u2026 maybe \u2026 because however impactful or not measures would be is sort of irrelevant in that it just wont pass muster with the British public,\u201d said Lowe.<\/p>\n

\nWhile neither side is yet to establish its negotiating mandates for a trade deal some are looking to Washingtons deals with Australia and South Korea as potential precedents.\n<\/p><\/blockquote>\n

In a statement, USTR said that \u201cthe United States believes that U.K. patients should have access to cutting-edge U.S. products and services through the NHS.\u201d<\/p>\n

\u201cWe would like the NHS to be able to purchase from U.S. firms on the same conditions as it purchases from any other firms, with the best interests of patients in mind,\u201d the department added.<\/p>\n

The U.K. government declined to comment for this article, pointing to a tweet<\/a> from Health Secretary Matt Hancock on Wednesday insisting that the National Health Service would not be on the table in any trade agreement.<\/p>\n

U.K. Foreign Secretary Jeremy Hunt said<\/a> this week that pharmaceuticals would be considered.<\/p>\n

Chilling effect<\/strong><\/h3>\n

The noise adds to existing pressure from drugmakers on the U.K. assessment process. Amid a yearslong impasse between U.S. pharma firm Vertex and U.K. regulators over the companys cystic fibrosis<\/a> drugs, Vertex last summer called on the U.K. to update its value assessment for innovation, in a letter<\/a> to Prime Minister Theresa May.<\/p>\n

Vertex CEO Jeff Leiden argued the \u201ccurrent processes have significant limitations in how they capture and value the full medical, societal, economic and innovation benefits of such precision medicines.\u201d<\/p>\n

NICE has already committed to review its assessment to take into account wider societal benefits, as part of the new five-year drug pricing deal<\/a> that began in January.<\/p>\n

<\/p>\n

A vintage chemist sign is displayed outside a independent chemist shop in Bath, England | Matt Cardy\/Getty Images<\/p>\n

But the status quo is also strongly supported. In 2013, NICE tried and failed<\/a> to deliver a new methodology that included wider societal benefits, such as effects on carers and the welfare system, and a rating for disease burden. It was unable to reach agreement among stakeholders, so the model was scrapped.<\/p>\n

Read More \u2013 Source<\/strong><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

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