No-deal Brexit could deepen Europe's shortage of medicines - experts


2019-08-13 10:35:00 YAHOO!FINANCE


As the Oct. 31 deadline for Britain to leave the European Union approaches, health professionals are warning that shortages of some medicines could worsen in Europe in the event of a no-deal Brexit. Britain's food and drink lobby warned last week that the country would experience shortages of some fresh foods if there is a disorderly no-deal Brexit. Pharmaceutical companies have expressed similar concerns about medicines, and some have reserved air freight capacity to fly in supplies if needed. . But the impact on medical supplies will also be felt beyond Britain. About 45 million packs of medicines are shipped from Britain to the rest of the bloc every month, in trade worth nearly 12 billion pounds ($14.5 billion) in 2016, according to a British parliament report. Experts say some disruption is inevitable if Britain leaves the EU without a deal. British Prime Minister Boris Johnson has said he will lead his country out of the EU on Oct. 31 without a deal if the EU refuses to negotiate a new divorce agreement. Some drugs might not have the required regulatory approval by then to continue being brought in from Britain. About 1 billion packs go in one direction or the other each year, industry data show. Increased customs controls at ports and other borders between Britain and the EU could also disrupt supplies of drugs and the chemical compounds needed to produce them, regulators and industry representatives say. "Despite intensive preparation by industry for every scenario, a no-deal Brexit risks disruption to the supply of medicines" throughout the EU, Andy Powrie-Smith, an official at the European Federation of Pharmaceutical Industries and Associations, told Reuters. The EU drugs regulator, the European Medicines Agency (EMA), said the bloc is well prepared for Brexit and has finalised authorisations for nearly all the 400 drugs under its watch that required further clearing because of Britain's impending departure. But authorisation is pending for three medicines that need EU-wide licences, an EMA official said without identifying them. Other essential medicines could also be blocked because of supervisory hurdles because of Brexit, EMA data show. The agency is the only body that can authorise sales in the 28-country EU of new drugs to treat the most common and serious diseases, including cancer, diabetes and flu. WORSENING WOES Many other medicines authorised at national level could also be at risk. Nearly 6,000 of these drugs need to go through a new licensing process after Brexit. The EMA official said the agency did not have "a full picture" of the situation in all EU states for nationally authorised medicines. The Netherlands said in February that 50 "critical" drugs were at risk of shortages in the event of a no-deal Brexit. Concerns about most of those drugs have since been resolved, a spokesman for the Dutch health ministry said, but problems could arise for less essential medicines. In a report in June, the EU's executive European Commission included medicines and medical devices in a list of sectors for which "continued and particular vigilance" was needed. Many EU states already face shortages of some medicines because of problems with production, regulators or distribution. A survey of 21 European countries showed that all of them experienced shortages of medicines last year, according to the Pharmaceutical Group of the European Union, a pharmacists' trade body. Vaccines were among the drugs most frequently cited as being in short supply. Britain will need to authorise hundreds of new medicines on sale now only thanks to EU-wide registrations. Britain imports about 37 million medicine packs every month from the EU, industry figures show. Britain is also losing supervisory and clinical-trial capacities as many operations have already moved to the EU to remain able to test and approve drugs for the EU market after Brexit. This trend could shrink the local pharmaceutical industry and lead to tighter supplies and higher costs. EU countries face the same logistical hurdles for their imports from Britain. In the event of Brexit without a divorce deal, "there will be some problems and delays in the supply chain due to border protocols, but I think we will be able to manage," said Eric Van Nueten, the chief executive officer of Febelco, Belgium's largest wholesale trader of medicines.
在10月31日英国脱离欧盟的最后期限临近之际,卫生专业人士警告称,如果英国退欧,一些药品的短缺可能会恶化. 英国食品和饮料游说团体上周警告称,如果英国无序退出欧盟,该国将出现一些新鲜食品短缺。制药公司对药品也表达了类似的担忧,有些公司在必要时保留了空运货物的能力。。 但对医疗用品的影响也会波及到英国以外的国家。根据英国议会的一份报告,英国每月大约有4500万包药品从英国运到欧盟其他地区,2016年的贸易额接近120亿英镑(145亿美元)。 专家们表示,如果英国没有达成协议就退出欧盟,一定程度的破坏是不可避免的。英国首相鲍里斯·约翰逊说,如果欧盟拒绝就新的离婚协议进行谈判,他将在10月31日带领他的国家脱离欧盟,而无需达成协议。 到那时,一些药物可能还没有获得必要的监管批准才能继续从英国引进。行业数据显示,每年大约有10亿个包装朝一个方向发展。 监管机构和行业代表表示,加强对英国和欧盟之间港口和其他边境的海关控制,也可能扰乱药品供应和生产这些药品所需的化合物。 欧洲医药工业和协会联合会官员 Andy Powrie-Smith 在接受路透社采访时说:“尽管各行业都在为每一种情况做大量准备,但英国脱欧可能会破坏整个欧盟的药品供应。” 欧盟药品监管机构——欧洲药品管理局( EMA )表示,欧盟已为英国退欧做好准备,并已敲定对其监管的近400种药品的授权。由于英国即将离职,这些药品需要进一步清算。 但一位欧洲药品管理局官员表示,三种需要欧盟范围内许可的药品尚待获得批准,但未对其进行确认。 EMA 数据显示,由于英国退欧导致监管障碍,其他基本药物也可能被阻止。 该机构是唯一能够授权欧盟28个国家销售治疗最常见和最严重疾病(包括癌症、糖尿病和流感)的新药的机构。 工作女性 许多国家一级批准的其他药物也可能面临风险。在英国退欧后,近6000种药物需要通过新的许可程序。 欧洲药品管理局官员说,该机构没有“全面了解”所有欧盟国家在国家授权药品方面的情况。 荷兰今年2月表示,一旦英国退欧,50种“关键”药物有可能出现短缺。荷兰卫生部的一位发言人说,对这些药物中的大部分的担忧已经得到解决,但不那么重要的药物可能会出现问题。 在6月份的一份报告中,欧盟执行委员会将药品和医疗器械列入需要“持续和特别警惕”的部门名单。 由于生产、监管或分销方面的问题,许多欧盟国家已经面临一些药品短缺的问题。 一项对21个欧洲国家的调查显示,所有这些国家去年都出现了药品短缺的情况,根据欧盟制药集团,一个药剂师的贸易机构。疫苗是最常被认为供应不足的药物之一。 英国将需要批准数百种新药物的销售,现在只有感谢全欧盟的注册。行业数据显示,英国每月从欧盟进口约3700万个药品。 英国也在丧失监管和临床试验能力,因为许多业务已经转移到欧盟,以便在英国退欧后仍能测试和批准欧盟市场的药品。这一趋势可能会缩小当地制药业的规模,导致供应紧张和成本上升。 欧盟国家从英国的进口面临同样的物流障碍。 比利时最大的药品批发贸易商 Febelco 的首席执行官埃里克·范努力克( Eric Van Nu称职)说,如果英国退欧而没有达成离婚协议,“由于边境协议,供应链将出现一些问题和延误,但我认为我们将能够管理。”