Legal Overview on Selling Medical Supplies to Italy 防疫物资出口意大利合规指引

分类:行业新闻发布时间:2020-04-17 15:27:04浏览:494
1. 意大利的防疫举措
社会,经济和遏制措施:
-作为欧洲受灾最严重的国家之一,意大利政府已通过了一项价值250亿欧元的紧急法令,以支持本已脆弱的经济,该国已因欧洲最严重的冠状病毒疫情而受重创。
- 自2020年3月9日起,意大利政府已下令关闭所有商店,酒吧和餐馆,但那些诸如药房和超级市场等基本必需品的商店除外,并禁止其6200万人次出行,除非经专业或健康证明是合理的,并要求人们待在家中。

2. 意大利对防疫物资的进口要求
(1)正常情况下
与所有欧盟国家一样,意大利政府也执行了与医疗设备和个人防护设备有关的欧盟指令和法规:医疗器械直销93/42 / EEC(MDD),法规(EU)2016/425和法规(EU)2017/745
·申请医疗产品CE认证时,公司应仔细考虑使用MDD还是MDR。 MDD下有56个公告机构,而MDR下只有12个。
·2020年4月3日,欧盟委员会通过了一项将MDR的应用推迟一年的提案,直到2021年5月26日,以允许成员国,卫生机构和经济运营商优先应对冠状病毒大流行。
·除了CE标记外,所有要放置在意大利的医疗设备都必须通过意大利卫生部(MoH)的数据库进行设备注册过程。登记程序的信息可在卫生部的网站上找到。
(2)在新冠肺炎疫情下
·根据D.l.第15条 2020年3月17日第18号决议,即所谓的“ Cura Italia”法令,国家卫生研究院和Confindustria Dispositivi Medici(意大利医疗技术公司协会)共同制定了技术数据表,确定了将医用口罩投放市场的基本要求 不带CE标志的医疗用途。
·国家卫生研究所在其网站上发布了自我认证,以证明对规章制度的推销具有必要的条件。
·根据ODCPC 630/2020和Dl。 11/2020,指定买家购买的医疗和流行病用品无需卖方银行担保即可提前付款!
·民事保护部门负责人可以“在面对COVID-19紧急情况时,从任何公共或私人实体没收任何种类的医疗产品或其他商品”。
(3)意大利产品责任
·在意大利,产品责任和产品安全均受《消费者法》(D.l 206/2005),欧盟法令以及部颁法令的约束。
·主管当局根据产品的性质以及所构成的危险或安全风险的程度具有广泛的权力。
·扣押和销毁货物;如果生产者和分销商采取的措施被认为无效或不足以解决安全风险,则责令其采取任何补救措施,撤回或召回产品。
·“瑕疵产品”
-“瑕疵产品”的定义包含在《消费者法》第117条中,根据该定义,当产品未提供考虑到所有情况的人有合理权利期望的安全水平时,该产品即为瑕疵产品,其中包括:
-产品的分配方式;
-产品的包装和明显的功能,以及提供的说明和警告;
-产品的合理预期使用和生命周期;和
-产品投放市场的日期。
·“责任方”
哪一方可以对次品负责?
-对于有缺陷的产品,制造商是主要的责任目标。
-在下列情况下,涉嫌有缺陷的产品的进口商,供应商或分销商也应承担责任:
制造商身份不明;或在收到受害方的要求或送达书面传票后的三个月内,供应商未向受害方提供制造商的身份。
(4)防疫用品国际销售合同起草
·“合同条款”
正确起草的合同可以减少出口商的法律风险,包括产品责任,侵权责任,违反合同责任等。
·在履行合同义务之前,请确保您已获得要出口的产品的批准和相应证明书!
·语言:
如果合同以中文和另一种语言起草,请确保在出现差异时规定解释规则
·商品简介:
为了尽可能避免基于双方未达成协议的标准提出索赔,请确保清楚地描述所售产品的技术规格。
·质量:
尽管各方可以在合同中规定质量限制,但是如上幻灯片中所述,意大利的《产品责任法》将始终保护消费者并将责任归于关联方。
·不可抗力:
意大利的几家商会已经开始颁发“ FM证书”,类似于中国贸促会在中国颁发的证书。考虑到FM条款在1999年《中华人民共和国合同法》下的影响,对于理解外国买家在COVID-19流行期间因“声称的FM”而违约的情况下的责任至关重要。
·适用法律:
一般来说,只要买家对此无异议,对任何国内卖家而言,将中华人民共和国法律适用于销售合同将是首选。
·争议解决:
几个关键方面,例如中国未加入1961年《海牙海牙公约》,法律和诉讼费用和成本不总是随败败方而定,以及一些声誉卓著的机构在中国的存在,都为当事方提供了建议在合同中有仲裁条款(CIETAC,GZAC等)。

1. Italian Mode to tackle COVID-19
Social, economic and containment measures:
- As one of the worst-hit country in Europe, Italy’s government, has adopted an emergency decree worth 25 billion euros to support an already weak economy battered by the worst outbreak of coronavirus in Europe.
- Italy’s government has ordered all shops, bars and restaurants to close except those selling basic necessities, such as pharmacies and supermarkets and banned its 62 million people from all travel unless certified as justified on professional or health grounds, and asked people to stay mainly at home since 9 March 2020.
2. Italy’s requirements on the import of epidemic protection supplies
(1)Under normal circumstances
·Like all European Union countries, Italian goverment has implemented European Union (EU) directives and regulations related to medical devices and PPEs: e.g. Medical Device Direct 93/42/EEC (MDD), Regulation (EU) 2016/425 and Regulation (EU) 2017/745
·When applying for CE certification of medical products, companies should carefully consider whether to use the MDD or the MDR. There are 56 Notified Bodies under the MDD, while  only 12 under the MDR.
·On 3 April 2020, the European Commission has adopted a proposal to postpone the application of MDR by one year – until 26 May 2021 to allow member states, health institutions and economic operators to prioritize the fight against the coronavirus pandemic.
·In addition to the CE marking, all medical devices to be placed in Italy must go through a device registration process with the database of Italian Ministry of Health (MoH). The information on registration procedures is available on the website of MoH.
(2)Currently under COVID-19
·Pursuant to Article 15 of D.l. No.18 of March 17, 2020, so called Decree “Cura Italia”, the National Health Institute and Confindustria Dispositivi Medici (the Italian Assosciation of Medtech Companies) jointly developed a technical datasheet identifying essential requirements for the placing on the market of surgical masks for medical use not bearing the CE marking.
·The National Health Insitute published on its website a self-certification in order to certify the possession of the necessary requirements for the placing on the market in derogation from the regulations.
·According to ODCPC 630/2020 and Dl. 11/2020, medical and epidemic supplies purchased by designated buyers can be paid for without seller’s bank guarantees and in advance!
· The Head of the Civil Protection Department can “confiscate from any public or private entity medical products or other goods of any kind, to the extend need to face the COVID-19 emergency". 
(3)Product liability in Italy
·In Italy, both product liability and product safety are governed by the Consumer Code (D.l 206/2005), and the EU Decrees, as well as Ministerial decrees.
·The competent authorities have a wide range of powers depending on the nature of the product and the degree of danger or safety risk posed. 
·Seizing and destroying goods; and ordering the remedy of any non-conformity, withdrawing or recalling products where the measures implemented by producers and distributors are considered ineffective or inadequate to address the safety risk. 
·“Product defect”
-The definition of ‘product defect’ is contained in Article 117 of the Consumer Code, pursuant to which a product is defective when it does not offer the safety level that a person is reasonably entitled to expect taking into account all circumstances, including:
- the way in which the product was distributed;
- the product’s packaging and evident features, and the instructions and warnings provided;
- the product’s reasonably expected use and life cycle; and
- the date on which the product was put into circulation.
·“Liable parties”
Which parties can be held liable for defective products?
- The manufacturer is the prime liability target in cases of defective products.
- The importer, supplier or distributor of the allegedly defective product may also be held liable when:
the manufacturer is unidentified; or the supplier does not provide the injured party with the identity of the manufacturer within three months from receiving a request from the injured party or the service of the written summons.
(4)Contract drafting for the international sales of Epidemic Prevention Supplies
·“Contract clauses”
A properly drafted contract can reduce the exporter's legal risks, including product liability, tort liability, breach of contract liability, etc.
·Before undertaking contract obligations, make sure you have obtained approval and according certificates for the product you wish to export!
·Language:
If the contract is drafted in both Chinese and another language, make sure to set forth the rules of interpretation in case of discrepancies
·Good’s Description:
In order to avoid as much as possible claims based on standards other than the ones agreed by the parties make sure to clearly describe the sold product’s technical specifications. 
·Quality:
Although parties can stipulate quality limitations under the contract, as mentioned in the above slide, Product Liability laws in Italy will always protect the consumers and attribute liabilities on related parties.
·Force Majeure:
Several chambers of commerce in Italy have already started issuing “FM Certificates” similar as the one issued in China by the CCPIT. Considering the effects of FM articles under 1999 PRC Contract Law will be key to understanding the foreign buyer’s liabilities during the COVID-19 epidemic in case of breach of contract due to “claimed” FM. 
·Applicable Law:
Generally speaking, as long as buyers are comfortable with this, having PRC Law applicable to the sales contract would be the preferred choice for any domestic seller. 
·Dispute Resolution:
Several key aspects, such as the P.R.China not joining the 1961 Hague Convention on Apostille, the legal and litigation expenses and costs not always following the losing party ex lege, and the presence in China of some very reputable institutions, all suggest for the parties to have an Arbitration Clause in their contracts (CIETAC, GZAC, etc).