by Guillaume Biétry
PARIS, Feb 2 (APM) - Drug stockouts are causing tension between pharma, wholesalers and pharmacists in the supply chain in France, experts have said.
During the discussions on Wednesday morning at a Federation of community pharmacists’ union (USPO) meeting, the organisation's vice-chair Pierre-Olivier Varot said 'stockouts' - where stocks of drugs run out - are becoming more frequent and prevent patients from receiving the drugs they need.
In its latest activity report, France’s drug regulator ANSM said it had managed 405 cases of drug supply tensions and stockouts in 2016, compared with 391 in 2015 and 173 in 2012.
Asked about this, Patrick Errard, chair of the French pharma industry body Leem, said he feels just as “angry” as the pharmacists though he stressed the problem is “particularly complicated to solve”.
He said at the meeting: “If stockouts were merely linked to manufacturers’ problems caused by quality problems in the production plants, you would only see 20% of the level of stockouts we currently face". He stressed that, apart from this 20% proportion, all the other stockouts should be avoidable.
He said avoidable issues include the fact there is tension on supply chains in specific periods of the year, and that this frequently affects products which are manufactured in one single plant which supplies the world. This is often the case with antibiotics and vaccines which tend to have longer manufacturing processes longer than other drugs.
Errard said these situations could be avoided if countries anticipated their needs more accurately and took better account of endemic changes.
Tensions can also occur because of exceptional demand linked to “panic effects” as with the recent Levothyrox (levothyroxine) affair. Thousands of adverse events were reported in France after Merck KGaA released a new formula of the thyroid hormone deficiency drug in March (APMMA 55157). The company subsequently changed it for a second new formula.
“Tensions also occur when distribution is poor, and we need to work on this problem, but it is also linked to the fact our plants and facilities are leaving France,” Errard commented.
In connection with this observation, he criticised the government’s pricing policy. He said that when prices fall too low, generic-manufacturers and pharma companies manufacturing older drugs tend to outsource production, and this affects supply.
He urged that "the production sites should remain in France,” and “mark-ups on the cheapest drugs need to be adequate,” he stated.
Stock pillaging
Finally, Errard said avoidable stockouts can be “provoked” by wholesale distributors building stock piles of drugs in order to export them.The Health Act of January 26, 2016 states that where a wholesale-distributor has completed its public service obligations (ensuring the continuous supply of the national market so it covers patients’ requirements in the distributor’s specific sector) it can sell stock outside the national territory or to wholesalers who specialise in exports.
“I understand your frustration, but imagine how we feel when our stock of a product has been pillaged - there is no other suitable term - and by the 15th of the month, there is nothing left," Errand said, noting this is despite the fact "we know perfectly well requirements are adequately covered in France”.
“They have the right (to export), it is European law and I don’t contest it. However, between this right and behaving unreasonably, there should be a middle ground that could suit one and all,” he added.
In response to the building up of stocks, pharma firms frequently impose quotas on wholesalers, leading once more to supply tensions or forcing pharmacists to deal directly with pharma companies.
At the same event, however, chief executive of the CERP France distribution network Marc Kénési set out to counteract Errard’s claims.
“How can you think that companies acting under the ethical authority of the order administered by pharmacists can apply a strategy aiming at stockouts?” he asked, pointing out that “44% of our turnover comes from products on a quota system,” adding “we play an essential shock absorber role in connection with this.”
Need for dialogue
Though the Health Act stipulates that wholesale-distributors can sell stock outside the national territory if obligations are met, it states that they "cannot sell drugs of major therapeutic interest …outside the national territory or to export wholesalers”. A decree and orders were published in summer 2016 specifying this notion of major therapeutic interest drugs (APMMA 48890) (APMMA 49014).A text listing the molecules which cannot be exported has yet to be published. According to USPO chair Gilles Bonnefond, discussions have been held but were not conclusive “owing to power struggles over the volume of the list, which some people find too extensive to be able to continue exporting, and others who find it too small to avoid quotas”.
Bonnefond called for the negotiations to resume. “We cannot continue to work under such conditions, with patients unable to adhere to their prescribed courses simply because the distribution circuit lets them down and does not allow them to access standard treatments,” he said.
Errard also said he is keen to discuss matters with all the stakeholders; “There are ways to sort these problems out,” he said.
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