It's a real move! Antitrust guidelines in the field of API are in place

Pharmaceutical Network Policy and Regulation: API is located in the upper reaches of the pharmaceutical industry chain, and when there is a monopoly of API, it often harms the legitimate rights and interests of patients and pharmaceutical companies.
, the monopoly behavior in the field of API still occurs from time to time.
in order to promote the healthy development of the API industry, maintain the order of competition in the API market, protect the interests of consumers and the public interest, prevent and stop monopoly in the field of API, and promote scientific and effective anti-monopoly supervision.
October 13th, the State Administration of Market Supervision issued the Antitrust Guidelines (Draft for Comments) on the Field of Raw Materials and Pharmaceuticals (hereinafter referred to as the Guidelines) for public comment until October 30th.
the Guidelines, API operators should comply with the relevant provisions of the Anti-monopoly Law and prohibit horizontal monopoly agreements with competitors.
For API production enterprises, it shall avoid reaching joint production agreements, joint purchasing agreements, joint sales agreements, joint tender agreements and other agreements with third parties (e.g., API distribution enterprises, downstream pharmaceutical production enterprises) to communicate sensitive information such as the sale price, production scale and production and marketing plan of API.
In the field of API, vertical monopoly agreements are reached mainly through distribution agreements between production or distribution enterprises and downstream enterprises, and may also be reached through oral agreements, written correspondence, e-mail, price adjustment notices, etc.
, the implementation of vertical monopoly agreements by individual API manufacturers or distribution enterprises will limit in-brand competition and harm the interests of downstream distributors and pharmaceutical manufacturers.
Especially when many or even all operators in the relevant market adopt similar vertical monopoly agreements, the competition in the API market will be significantly weakened, harming the interests of API distribution enterprises and pharmaceutical production enterprises, making the prices of API and related drugs significantly higher than the level of competition, and harming the competition in the API and related pharmaceutical markets.
the recognition of vertical monopoly agreements in the field of API, the relevant provisions of drug association review and approval may be considered.
At the same time, API manufacturers or distribution enterprises with a dominant market position may abuse their dominant market position, for example, the sale of API at unfairly high prices, the refusal to sell API, the limited transaction involving API, the tying of API, the additional unreasonable trading conditions involving API, the differential treatment involving API, and the common abuse of market dominance.
the abuse of market dominance involving raw materials, the provisions of Chapter III of the Antimonopoly Law shall apply.
the Guide proposes to re-deal with the monopoly of API in accordance with the law.
supply and price stability of raw materials and medicines are related to the safety of people's lives and vital interests.
China's api monopoly behavior is frequent, operators have a high degree of awareness of monopoly behavior, API operators to carry out monopoly behavior, especially knowing that the relevant acts in violation of the Anti-monopoly Law still deliberately evade anti-monopoly investigation, anti-monopoly law enforcement agencies will be in accordance with the provisions of Article 46, Article 47, 49 of the Anti-monopoly Law, taking into account the nature, extent and sustainability of illegal acts and other factors, strictly deal with.
, in order to better protect the basic drug demand of the masses, cracking down on the monopoly of API has become one of the key contents of the pharmaceutical industry consolidation.
The Price Behavior Guide for Operators of Shortage drugs and API, issued in 2017, has become the first price monopoly guide for this particular industry since the implementation of China's anti-monopoly law, and the Opinions on FurtherIng the Work of Maintaining prices for Shortage Drugs also explicitly increase the enforcement of illegal acts such as the monopoly of RAW drugs.
under strict supervision, api companies are not a minority of cases of punishment for monopoly behavior, the state level has issued huge fines for monopoly cases of API enterprises.
now, with the introduction of anti-monopoly guidelines in the field of API, enterprises also need to regulate production behavior in order to sustain and healthy development.