Preventing acquisition by foreign capital - competition for pharmaceuticals and medical items for Corona

Recently Nihon Keizai Shimbun Electronic Version reported the following:

外資の買収阻止、医薬品・医療機器も　コロナで争奪戦

2020/4/22 18:00 (2020/4/23 5:24更新) 日本経済新聞　電子版

新型コロナウイルスの感染拡大を受け、政府は高度な医薬品や医療機器の分野で外資による日本企業の買収阻止に動く。5月に施行する改正外為法で、感染症に関わるワクチンや医薬品、人工呼吸器などの高度医療機器を安全保障上、特に重要な業種に追加する。中国などによる買収を念頭に対策を急ぎ、世界的に争奪戦が広がる医薬品・医療機器の安定供給につなげる。

新型コロナをきっかけに、予防・治療のための医療事業の重要性は高まっている。米トランプ政権がドイツの新興企業にワクチンの独占供給を迫ったとして、独メディアが問題視した件もあった。日本政府は重要な技術や生産設備がチェックが緩いまま外資に買収されれば、国の安全を損なう恐れが大きいとみる。

外為法では安保上、重要な日本企業の株式を外国人投資家が取得する際、事前の届け出を求める。2019年秋に成立した改正外為法では、その基準を持ち株比率で「10%以上」から「1%以上」に厳しくした。

  

その上で、もっとも厳格な規制をかける「コア業種」として、武器、原子力や鉄道、サイバーセキュリティーなど12分野を挙げた。コア業種は外国人投資家による株式取得を事前に厳しく審査する。医薬品や医療機器はこの12分野に入れておらず、近く改正外為法の告示で2分野を追加する。一般から意見を募り、7月にも適用する見通し。

医薬品では感染症の予防・治療に必要な事業を対象にする。具体的には原材料や医薬品、製剤、ワクチン、血清などを含める。新型コロナへの治療効果が期待され、政府が備蓄を急ぐ富士フイルムホールディングスの抗インフルエンザ薬「アビガン」の製造事業などが想定されている。

医療機器では、法律により高度な製造や品質管理が求められる事業をコア業種に加える。人工心肺や人工呼吸器、輸液ポンプや人工透析器など、感染症がまん延したときに代替製造が難しい製品が対象となる。

コア業種の企業でも、外国人投資家が出資先企業の経営に関与しないなど一定の条件を満たした場合には、事前届け出の免除規定が適用される。

新型コロナの影響の広がりを背景に、医療・医薬関連の物資はエネルギーなどと並ぶ国防上、重要な戦略物資になってきた。欧州連合（EU）のレナルチッチ欧州委員（危機管理担当）は、人工呼吸器など重要な医療資材・機材が「秩序ある調達の手配が困難」な状況になっていると警告した。

欧州でもイタリアなどがヘルスケア産業を対象に外資規制を強化しており、パンデミックを機に安保の裾野が経済や技術分野に一段と広がっている。同時に、各国が一方的な保護主義に陥らないよう、国際的な協力を進める枠組みの再構築も課題になる。

（税財政エディター・小滝麻理子、辻隆史）

Translation

Following the spread of the new coronavirus infection, the government would move to prevent foreign companies from acquiring Japanese companies in the fields of advanced medicines and medical devices. For the purpose of securing vaccines related to infectious diseases, pharmaceuticals, artificial respirator etc. advanced medical equipment, certain particularly important types of industry would be added to the revised Foreign Exchange Law that would come into effect in May. Taking into account acquisitions by China and other countries, the government would take urgent measures to lead to a stable supply of pharmaceuticals and medical devices that were increasingly competed for worldwide.

With the new corona, the importance of the medical business to do prevention and treatment was increasing. There was also a case in which a German media saw problems as the US Trump administration pressed for a monopoly in vaccine supply from a German start-up enterprises. The Japanese government thought that there would be a great national security risk if medical business was acquired by foreign capital for reason that important business technology and production equipment were not being monitored closely.

The Foreign Exchange Act required, for security reasons, foreign investors to register in advance when acquiring shares of important Japanese companies. Under the revised Foreign Exchange Law that was enacted in the fall of 2019, the stock holding ratio threshold triggering point was tightened from exceeding 10% to exceeding 1%.

On top of that, 12 fields such as weapons, nuclear power, railways, and cyber security were listed as the “core industries” that had the strictest regulations imposed. The core industry strictly examined the acquisition of shares by foreign investors in advance. Pharmaceuticals and medical devices were not included in these 12 fields, and these two fields would be added in a notification of the revised Foreign Exchange Law soon. It was expected to receive opinions from the general public and would be applicable in July.

For pharmaceutical products, it would become a targeted business for its need to prevent and treat infectious diseases. Specifically, raw materials, pharmaceuticals, formulations, vaccines, serum, etc. would be included. What was envisioned was the manufacturing business such as Fujifilm Holdings' that made the anti-influenza drug "Abigan" with an expectation to have therapeutic effects on the new corona, and that the government could stockpile this drug urgently.

In medical equipment, businesses that required advanced manufacturing and quality control by law were added to the core industries list. Products that were difficult to substitute when infections spread, such as artificial heart-lung machines and respirator, infusion pumps, and artificial dialyzers etc. were the targets.

Even for companies in core industries, exemption provisions  might be applicable on advance notification when foreign investors could meet certain conditions, for example they were not involved in the management of the invested company.

Against the background of a widespread impact of the new Corona, medical and pharmaceutical-related goods had become important strategic goods for national defense along with energy. European Union Commissioner Lenaručić (in charge of crisis management) warned that for important medical materials and equipment such as ventilators, "orderly procurement were difficult to arrange."

In Europe as well, Italy and other countries were tightening regulation on foreign capital for the healthcare industry, and the pandemic had taken the opportunity to expand the scope of security to include economic and technological fields. At the same time, the challenge was to rebuild the framework for promoting international cooperation so that countries did not fall into one-sided protectionism.

              So, Japan, like many other countries, is tightening its control over medical and pharmaceutical-related goods production. These items are considered as important strategic items for national defense.