Legal Overview on Selling Medical Supplies to Italy 防疫物资出口意大利合规指引
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
·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。
·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！
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.
-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.
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
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!
If the contract is drafted in both Chinese and another language, make sure to set forth the rules of interpretation in case of discrepancies
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.
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.
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.
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.
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).