Stronger enforcement and sanctions for pharmaceutical infringements
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This article explores key developments in competition law enforcement in pharmaceuticals in the Asia-Pacific region over the past 18 months, discussing the efforts of competition authorities to pursue potential infringements by companies and their readiness to impose significant sanctions. Looking ahead, it considers the potential focus of further competition law enforcement as it relates to this sector in the Asia-Pacific region.
- Cartels and anticompetitive agreements regarding pharma products
- China’s competition authorities’ actions against abuses of dominance
- India and the Philippines’ authorities’ monitoring of pharmaceutical sector
- Indications of approach to patent settlements in Australia, China and South Korea
- Cases motivated by concerns about pricing and access to essential medicines
Referenced in this article
- Australian Competition and Consumer Commission
- China’s State Administration for Market Regulation
- Competition Commission of India
- Japan Fair Trade Commission
- Korea Fair Trade Commission
- Philippine Competition Commission
Criminal cartel conduct
The Australian Competition and Consumer Commission (ACCC) has recently successfully concluded a criminal prosecution regarding an international cartel in the pharmaceutical sector. On 1 December 2020, the Commonwealth Director of Public Prosecutions filed criminal charges against Alkaloids of Australia Pty Ltd (AOA) and its former export manager, Christopher Kenneth Joyce, for cartel conduct relating to the supply of active pharmaceutical ingredient (API) scopolamine N-butylbromide (SNBB) in contravention of the Competition and Consumer Act 2010 (CCA), following a criminal investigation by the ACCC.
SNBB is manufactured from the alkaloid scopolamine. Scopolamine is extracted from Duboisia plants, which are native to Australia. AOA is a supplier of SNBB and the only manufacturer in Australia.
AOA and Joyce were both originally charged with 33 criminal cartel offences spanning a period of almost a decade from 2009, involving allegations that AOA and other international suppliers of SNBB made and gave effect to arrangements to fix prices, restrict supply, allocate markets and customers, and rig bids for the supply of SNBB to manufacturers of generic antispasmodic medications.
The original charges were restructured and, over October and November 2021, Joyce and AOA both pleaded guilty to three cartel offences and also admitted guilt in respect of a further seven offences. The three cartel offences to which Joyce and AOA pleaded guilty related to conduct involving:
- fixing a minimum price for the supply of SNBB at between US$1,500 and US$5,000 per kilogram;
- agreeing to acquire the entire supply of Duboisia leaves from a particular grower (who was also required to commit to not grow or produce Duboisia on certain property); and
- attempting to fix the price of SNBB so that it was inversely tiered based on the quantity to be supplied, with a minimum price of no lower than US$1,500 per kilogram.
On 29 November 2022, AOA and Joyce were convicted and sentenced by the Federal Court of Australia in relation to the three cartel offences to which they pleaded guilty. AOA was sentenced to pay a fine of A$1,987,500 and Joyce received an aggregate sentence of 32 months’ imprisonment to be served by way of an intensive correction order. This is the longest imprisonment sentence that has been imposed on an individual for criminal cartel conduct in Australia to date. Joyce was also ordered to perform 400 hours of community service and pay a fine of A$50,000, and has been disqualified from managing corporations for a period of five years. The Federal Court described the conduct as ‘deliberate, systematic, coordinated and covert’. However, the court also applied a 25 per cent discount to the sentences in recognition of the early guilty pleas entered by the defendants.
Intellectual property licences and patent settlements
Following the repeal in September 2019 of a safe harbour exemption in the CCA for certain conditions in intellectual property (IP) licences or assignments, all IP assignments or licensing arrangements are now subject to the entire CCA, including the cartel prohibitions. There have been reports of the ACCC’s cartels branch initiating investigations into restrictions in distribution agreements, IP licences and patent settlement agreements for pharmaceuticals, but no proceedings have been commenced at this stage.
If parties to a licence or assignment of IP rights could be competitors, it is important to assess whether there are any conditions that set prices, restrict output or sales, or allocate markets (including disease areas, customers and territories) that could be viewed as cartel provisions. In addition to exposing the parties to prosecution, conditions that contravene the CCA would also be void and unenforceable.
On 3 December 2021, the ACCC received an application for authorisation of a patent settlement and licence agreement (PSA) from Juno Pharmaceuticals Pty Ltd (Juno), Natco Pharma Ltd (Natco), Celgene Corporation and Celgene Pty Ltd (together, Celgene). Celgene owns patents for Revlimid and
Pomalyst – medicines used to treat certain forms of blood cancer. The application to the ACCC concerned provisions in the PSA that would enable Juno and Natco to supply generic versions of the medicines from an entry date specified for each medicine.
When considering whether to grant an authorisation, the ACCC exercises a discretion as to whether the relevant public benefit test is satisfied (outweighing the detriment arising from a lessening of competition). On 23 March 2022, the ACCC published a draft determination regarding Juno, Natco and Celgene’s application that proposed to deny authorisation due to a lack of information provided about the public benefits of the PSA and its effect on competition. The ACCC considered, the PSA had the potential to result in anticompetitive effects, but was not satisfied, it would give rise to public benefits that would outweigh the potential detriment.
The ACCC’s concerns regarding the potential detriment arising from the PSA appear to have been focused on the PSA’s entry date provisions. In particular, the ACCC indicated that a specified entry date might reduce the competitive constraint posed by the threat of generic entry by providing greater control and certainty of the timing of generic entry, and might deter other generic entrants by conferring a first-mover advantage on one generic manufacturer.
On 29 July 2022, Celgene, Juno and Natco withdrew their application for authorisation without explanation, which ended the ACCC’s consideration of the application prior to a final determination. This was the first application to the ACCC for authorisation relating to a PSA since the repeal of the IP exemption, which parties might have previously relied upon when assessing PSAs. Although the ACCC did not make a final determination, the draft provides indications of the ACCC’s approach to assessing PSAs and might foreshadow a more active role in relation to PSAs in the future.
During September and October 2020, in the context of the covid-19 pandemic, the ACCC granted a number of final authorisations to allow members of various pharmaceutical industry associations, pharmaceutical wholesalers, medical oxygen suppliers and suppliers of medical equipment to cooperate to ensure security of supply of essential medicines and related devices, pharmacy products, medical oxygen, medical equipment and related supplies, respectively, if shortages were to occur as a result of the pandemic. These authorisations are subject to conditions that allow the ACCC to monitor the authorised conduct. Under the CCA, the ACCC may grant authorisations to provide businesses with legal protection for conduct that might otherwise contravene the CCA but is not harmful to competition or is likely to result in overall public benefits, or both. The ACCC also granted a number of interim authorisations in early 2020, at the beginning of the pandemic, in some cases in extremely short time frames.
On 6 September 2021, pharmaceuticals wholesalers applied for re-authorisation to continue to cooperate in providing access to essential medicines and pharmacy products during the continuing covid-19 pandemic. On 13 September 2021, the ACCC granted an interim authorisation to pharmaceutical wholesalers to allow the cooperation to continue while the ACCC considered the re-authorisation application. On 17 February 2022, the ACCC made a determination granting re-authorisation to enable the cooperation to continue, including in relation to the distribution of covid-19 vaccines, subject to a monthly reporting condition. The re-authorisation has been granted until 28 February 2023. These authorisations continue alongside authorisations for each Australian state and territory government to coordinate with private healthcare providers in relation to their responses to the covid-19 pandemic until 24 June 2023. At this stage, it is unclear whether further re-authorisations will be sought or granted in relation to the covid-19 pandemic in 2023.
Enforcement by the State Administration for Market Regulation
China’s State Administration for Market Regulation (SAMR) has continued to strongly enforce competition law in the pharmaceuticals and medical products sectors. Competition law enforcement under China’s Anti-monopoly Law 2008 (AML) has been used in conjunction with other regulations and policy reforms to address concerns in these sectors, such as increasing prices and supply shortages.
SAMR has focused its AML enforcement activities in the pharmaceutical industry on domestic suppliers of APIs. The AML has been applied to abusive conduct involving excessive pricing, refusals to supply and imposing unfair trading conditions by API suppliers, and anticompetitive price-fixing and market-sharing agreements among competing firms in the API sector.
On 30 January 2022, the Ministry of Industry and Information Technology issued a directive that reiterated China’s commitment to addressing antitrust conduct in the API sector. The directive notes that drug shortages and anticompetitive practices will be addressed by the Chinese government, complementing the Antitrust Guidelines in the Field of Active Pharmaceutical Ingredients (the API Guidelines) issued by SAMR on 15 November 2021. The API Guidelines provide guidance for the API sector on the types of business practices that might contravene the AML (such as refusals to deal, tying and discriminatory behaviour) and provide information about SAMR’s approach to market definition (including the circumstances in which the product dimension of the market might be broader than a single API). The API Guidelines are intended to assist SAMR’s API enforcement activities, which remains an enforcement priority, and increase compliance with the AML by providing greater legal certainty.
Throughout 2022, SAMR also focused on anticompetitive practices relating to medical supplies used to treat covid-19. On 9 December 2022, SAMR issued a warning letter to suppliers of medicines and medical equipment used in the treatment of covid-19. Suppliers were warned against engaging in anticompetitive conduct such as collusion and unfair price hikes, and were cautioned against false advertising and fraud.
The cases outlined below illustrate the ongoing focus on pharmaceuticals and the API sector by Chinese antitrust authorities at both the national and regional levels.
Enforcement by regional market regulators
SAMR’s enforcement efforts in relation to the API sector have been supported by action taken by regional market regulation authorities.
On 16 July 2021, the local Administration for Market Regulation (AMR) in the province of Jiangsu fined three manufacturers of medicinal camphor – Wuzhou Huangpu Chemical Pharmaceutical (Huangpu), Suzhou Youhe Science and Technology (Youhe) and Jiangsu Jiafu Pharmaceutical (Jiafu) – for price fixing and market allocation. Medicinal camphor is an API used in treatments for common ailments such as coughs and skin conditions. Huangpu, Youhe and Jiafu are the only manufacturers of medicinal camphor in China. The companies agreed to maintain the sales price of medicinal camphor and avoid a price war. Youhe also entered into agreements with Huangpu that required Youhe to cease medicinal camphor production and source the API from Huangpu, maintain the minimum sales price of the API, and help Huangpu increase its market share to a certain level by directing its customers to Huangpu. If Youhe failed to meet these requirements, it would be penalised with higher pricing from Huangpu for supply of the API or termination of supply. The Jiangsu AMR determined that Huangpu, Youhe and Jiafu had breached the prohibition of anticompetitive agreements between competitors under the AML and imposed fines of 8.96 million yuan for Huangpu and Youhe and almost 800,000 yuan for Jiafu and confiscated illegal gains from the companies. Huangpu appealed against the fine but the Jiangsu High People’s Court and SAMR dismissed Huangpu’s appeal in November 2022.
On 27 September 2021, the Henan AMR imposed a penalty of 11 million yuan on Shangqiu Xinxianfeng Pharmaceutical (Xinxianfeng) for abuse of dominance in the sale of the API phenol in China (mainly used in preparations to sterilise surgical instruments). The penalty included a fine amounting to 1 per cent of Xinxianfeng’s revenue in 2016 and confiscation of illegal gains. Xinxianfeng had entered into an exclusive distribution agreement for phenol with the only manufacturer of the API in China, Chongqing Southwest No. 2 Pharmaceutical Factory. As a result of that distribution agreement and other tactics such as bulk purchasing, the Henan AMR found that Xinxianfeng had a market share for phenol ranging from 82.95 per cent to 100 per cent between 2014 and 2017. Xinxianfeng was deemed to be dominant because its market share was greater than 50 per cent. The Henan AMR determined that Xinxianfeng abused its dominance by forcing hospitals and manufacturers of phenol preparations to pay unfairly high prices for phenol on the basis that the prices were 6.8 to
9.2 times the historical market price.
On 18 November 2021, the Shanghai AMR imposed a penalty of 6.6 million yuan on Nanjing Ningwei Pharmaceutical (Ningwei) for abuse of dominance in the supply of the API pralidoxime chloride (used for injections to treat pesticide poisoning) in China by imposing unfairly high prices and unreasonable trading terms. The penalty included a fine amounting to 4 per cent of Ningwei’s revenue in 2019 and confiscation of illegal gains. Ningwei was the exclusive distributor for the only company that was manufacturing the API during the relevant period. The Shanghai AMR determined that the sales price charged by Ningwei was unfairly high on the basis that it was five to 10 times the price at which it purchased the API and 26.09 to 52.17 times the historical market price. The unreasonable trading terms included requiring a customer pay substantial damages for breach of contract if it did not purchase a fixed amount, setting a minimum purchase amount that exceeded the customer’s actual demand for the API and requiring a customer pay technical fees when no technical services were provided.
On 18 November 2022, the Tianjin AMR announced that it intended to impose a fine of 27.72 million yuan on Tianjin Jinyao Pharmaceutical (Jinyao) for abuse of dominance in the market for carmustine injections by selling the drug at unfairly high prices. Carmustine is a chemotherapy drug used in the treatment of brain tumours. To rectify the conduct, Jinyao has significantly reduced the sales price of carmustine injections and increased supply to ensure access to the drug.
Private lawsuits raising AML contraventions are also emerging in the Chinese API and pharmaceuticals sectors.
On 17 December 2021, China’s Supreme People’s Court (SPC) provided guidance to Chinese courts regarding the treatment of patent settlements, particularly in the context of patent lawsuits. The SPC provided the guidance in a ruling permitting an application by AstraZeneca to withdraw an appeal of a patent infringement lawsuit. AstraZeneca’s lawsuit was originally filed in the Nanjing Intermediate People’s Court in October 2020 and alleged that a Chinese company, Jiangsu Aosaikang Pharamceutical (Aosaikang), had infringed its patent by manufacturing and registering saxagliptin tablets (used to treat high blood glucose in type 2 diabetes patients). The Nanjing Intermediate People’s Court had found in favour of Aosaikang on the basis that it was entitled to engage in the infringing activities under a prior settlement agreement that had been reached between a third party, Bristol-Myers Squibb (the original patent holder), and an affiliate of Aosaikang, Jiangsu Vcare PharmaTech. AstraZeneca appealed that decision to the SPC.
AstraZeneca and Aosaikang then reached a new settlement and AstraZeneca made an application to the SPC to withdraw its appeal. In its ruling, the SPC indicated that Chinese courts must review patent settlements for AML violations when considering whether to allow withdrawal applications. The SPC stated that, in non-antitrust matters such as AstraZeneca’s lawsuit, it was sufficient if courts performed a preliminary review of the patent settlement for AML violations. In allowing AstraZeneca’s application, the SPC stated that there was no longer a possibility of an AML violation because the patent had already expired in the previous calendar year and was no longer an obstacle to market entry. The SPC also made observations in relation to the prior settlement agreement between Bristol-Myers Squibb and Jiangsu Vcare PharmaTech, finding that the agreement had the characteristics of a reverse payment agreement in that the patent holder agreed to compensate the generic and the generic agreed to not challenge the validity of the patent or to delay market entry.
Resale price maintenance
In the pharmaceuticals and medical device sectors, the AML continues to be applied to address resale price maintenance (RPM) in agreements with firms at different levels of the supply chain.
On 9 February 2022, SAMR fined Geistlich Pharma’s Chinese subsidiary Geistlich Trading (Beijing) (Geistlich) 9.1 million yuan for engaging in RPM between 2008 and 2020 in relation to its Bio-Oss and Bio-Gide medical devices, which are used for regenerative dentistry. Bio-Oss is used to substitute natural bone and Bio-Gide is a collagen membrane used for bone regeneration. SAMR found that Geistlich signed and implemented agreements with distributors providing that resale prices should not be lower than a certain percentage of the recommended prices set by Geistlich, and expressly required compliance with these terms in verbal communications and over the WeChat platform. SAMR also found that Geistlich monitored the implementation of these RPM agreements and penalised distributors for non-compliance. SAMR noted that there are high barriers to entry for Class III medical devices in China, which placed Geistlich in a strong position to require its distributors comply with the RPM requirements. The fine represents 3 per cent of Geistlich’s revenue in China for 2020.
On 24 June 2022, the Hainan AMR imposed a fine of 200,000 yuan on Hainan Yishun Pharmaceutical for engaging in RPM in relation to the price of the anti-inflammatory supplement Lianzhi Xiaoyan Pian. Lianzhi Xiaoyan Pian is used in the treatment of coughs, asthma, and other throat and respiratory issues. The Hainan AMR found that, during the period from 2019 to 2020, Hainan Yishun Pharmaceutical signed three versions of agreements with distributors that contained RPM restrictions and penalties for non-compliance.
The Competition Commission of India (CCI) has investigated numerous allegations of anticompetitive practices in the pharmaceutical sector. These investigations have been largely concerned with alleged anticompetitive agreements in the distribution of pharmaceuticals, and have particularly scrutinised the practices of industry associations and the involvement of pharmaceutical companies and their executives in supporting those practices.
The CCI continues to be particularly concerned with a practice of district-level chemists’ associations to require a no-objection certificate (NOC) prior to the appointment and supply of pharmaceuticals to distributors. The CCI has found that this practice results in limiting and controlling the supply of pharmaceuticals in India. Individuals from various pharmaceutical companies have also been held liable for such practices through either active involvement or holding key positions in the associations that engaged in the anticompetitive practice. Cease-and-desist orders and substantial penalties have been imposed on associations, pharmaceutical companies and individuals.
Other practices of chemists’ associations that the CCI has previously determined were anticompetitive and continues to investigate include obligations upon pharmaceutical companies to pay these associations compulsory product information service charges to launch their new products.
On 18 November 2021, the CCI released the findings of a market study of the pharmaceutical sector in India, which it had launched in October 2020. The study was initiated due to the importance of access to affordable, quality medicines for public health and the numerous competition law cases relating to the pharmaceutical sector in India. Another factor in the CCI’s decision to launch the study was the covid-19 pandemic, which had increased demand and accelerated consumer spending on healthcare in India.
The study found that there is a prevalence of branded generics in India and a high degree of price variation between different generics of the same molecules, with branded generics likely to have higher prices than unbranded generics. The CCI found that this was likely driven by consumer perceptions of the higher quality of certain brands, which was reinforced by the marketing strategies of pharmaceutical companies to achieve a brand premium on prices. The CCI considered that consumer preferences for branded drugs was a barrier to effective price competition for generics in India. The CCI noted the difficulty of obtaining information about the quality of low-priced generic versions and considered that it was important to dispel concerns about drug quality to increase price competition. The CCI noted that large-scale public information campaigns could be launched to raise consumer awareness of the cost efficiency and efficacy of generic drugs.
In relation to the practices of industry associations, the CCI observed that feedback received in the study indicates that the CCI’s enforcement efforts have generally had a positive impact to discontinue mandatory requirements for NOCs to appoint stockists and levying product information service charges for the introduction of new drugs, although some instances of these practices persist.
Regarding trade margins, the CCI warned that it would continue to target enforcement and advocacy efforts to deter and prevent industry associations and competing players across the pharmaceutical supply chain from colluding on trade margins and fixing, restricting or discouraging discounts by chemists and stockists.
The study also considered the recent growth of online e-pharmacies in India and concerns about the collection, storage, securing and sharing of sensitive personal data of consumers, which the CCI noted could be a competition harm. The CCI recommended that e-pharmacies adopt self-regulatory measures at an industry level on safeguarding privacy when collecting, using and sharing data.
Abuse of dominance
Throughout 2022, the CCI considered a series of complaints concerning abuse of dominance by pharmaceutical companies.
On 25 October 2022, the CCI dismissed a complaint against Vifor International (Vifor), a Switzerland-based pharmaceutical company, concerning the sale of injectables containing ferric carboxymaltose (FCM). Vifor holds a patent over FCM injectables, which are used to treat iron deficiency. Vifor had entered into exclusive licensing agreements for FCM injectables with Emcure Pharmaceutical and Lupin in India. The complaint against Vifor alleged that Vifor had abused a dominant position by entering into exclusive licensing arrangements to restrict the production and supply of FCM injectables. The complaint also alleged discriminatory and excessive pricing of FCM injectables. In dismissing the complaint, the CCI stated that there was no evidence that Emcure and Lupin could exclude rivals and that there was nothing to impede the entry of suppliers of other iron injectables. The CCI also noted that the arrangements were short term, with the relevant patent set to expire in 2023. In relation to pricing, the CCI noted that price differences might not be discriminatory when they are based on a reasonable classification of consumers or offered in government procurement. In this case, Vifor had initially disputed the CCI’s jurisdiction to consider the complaint on the basis that it would encroach on the domain of the Office of the Controller General of Patents, Designs and Trade Marks. The CCI dismissed this objection, confirming that it was entitled to review antitrust issues where patents and other forms of IP are involved.
On 14 October 2022, the CCI dismissed a complaint against Sanofi concerning a refusal to supply certain products at wholesale prices. The CCI noted that there were 17 distributors in the relevant market from which the complainant could secure products and that there were generic versions or substitutes for the relevant products in the market. The CCI concluded that Sanofi’s decision not to deal directly with the complainant was not likely to have an adverse effect on competition.
On 13 June 2022, the CCI dismissed a complaint against Sun Pharmaceutical Industries (Sun). A retail chemist alleged that Sun had unfairly increased the maximum retail price of coronavirus antiviral medication during the covid-19 pandemic. The CCI noted that there were over 40 substitutes for the Sun antivirals and the relevant market was very competitive, so Sun was unlikely to have market power.
The Japan Fair Trade Commission (JFTC) continues to investigate collusion between competitors in the pharmaceuticals sector following the successful criminal prosecution and administrative sanctioning of the Japanese pharmaceutical wholesalers Alfresa Corporation (Alfresa), Suzuken Corporation (Suzuken) and Toho Pharmaceutical Corporation (Toho), as well as seven officials at the three companies, for bid rigging in relation to the supply of prescription medicines to 57 hospitals operated by the Japan Community Healthcare Organisation. On 9 November 2021, the JFTC conducted raids on six pharmaceutical wholesalers including subsidiaries of Alfresa, Suzuken and Toho. According to the reports, it is alleged that the wholesalers had engaged in bid rigging for tenders to supply hospitals in the Kyushu region since 2016.
There are also reports of the JFTC commencing investigations of unilateral abuses and anticompetitive tying arrangements in the pharmaceuticals sector by conducting further raids. On 19 April 2022, it was reported that the JFTC had conducted a raid of Daikoku, which operates a chain of pharmacies. According to reports, it is alleged that Daikoku abused its superior bargaining power by unfairly forcing suppliers to accept the return of medicines and other inventory from closed Daikoku stores. On 13 December 2022, it was reported that the JFTC had conducted a raid of both Johnson & Johnson and its former subsidiary, ASP Japan. According to reports, it is alleged that the companies obstructed competitors from supplying cleaners and disinfectants for endoscopes by requiring that customers use only their products.
For the Philippine Competition Commission (PCC), healthcare and the pharmaceutical industry remain priority sectors for enforcement. Following the completion of an industry-scoping study and publication of an issues paper and policy note in 2020 that identified key challenges in the Philippine pharmaceutical industry, the PCC warned pharmaceutical companies to expect more scrutiny in the future.
On 10 January 2022, the chair of the PCC announced the PCC’s 2021 Year-end Report, which stated that the Competition Enforcement Office of the PCC opened 10 full administrative investigations in 2021 with healthcare companies among the firms investigated. The 2021 Year-end Report also mentioned that one of the two statements of objections filed by the PCC’s Competition Enforcement Office involved an alleged price-fixing cartel in the healthcare industry. This matter will now proceed to adjudication.
The 2021 Year-end Report also highlighted that the PCC convened the Pharmaceutical Technical Advisory Group in September 2021, which comprises sectoral experts in economics, medicine, regulatory policy and competition policy, to advise and assist the PCC and its partner agencies in initiating more pro-competitive strategic interventions in the sector.
On 25 July 2022, in his inaugural state of the nation address, President Ferdinand R Marcos Jr referred to the need to ensure competition in the pharmaceuticals market to secure more accessible and lower-priced medicines for Filipinos. The following day, the PCC released a formal statement supporting the President and reaffirmed its focus on the pharmaceutical industry. More specifically, the PCC highlighted its commitment to crack down on cartels and abusive conduct. Although there have not been any major enforcement outcomes in the past year, there remains a high level of focus on the pharmaceutical industry in the Philippines.
Since announcing that its 2021 enforcement priorities would include a focus on the pharmaceutical sector, the Korea Fair Trade Commission (KFTC) has successfully concluded a number of investigations into pharmaceutical companies.
On 10 January 2022, the KFTC announced that it had reached an administrative resolution in its investigation of Ildong Pharmaceutical for RPM. The KFTC found that Ildong Pharmaceutical had set a minimum price for the sale of dietary supplements between December 2016 and May 2019, monitored the pricing of online resellers and distributors, and restricted supply if a company did not comply with its minimum price requirements.
On 13 October 2022, the KFTC fined AstraZeneca and Alvogen 2.65 billion won for colluding not to launch a generic cancer treatment. The KFTC found that Alvogen had agreed to suspend its plans to launch a generic version of AstraZeneca’s Zoladex in return for the exclusive rights to supply three AstraZeneca drugs in South Korea. The KFTC noted that AstraZeneca had considered Alvogen’s generic a significant threat to its business. The KFTC determined that AstraZeneca and Alvogen had entered into an anticompetitive agreement with the effect of preventing the launch of generic drugs, thus preventing a resulting price decrease, stifling innovation and increasing the burden of drug prices on consumers by depriving them of the option to choose a generic drug.
 The author wishes to thank Gilbert + Tobin lawyers Robert Albertson Kill and Shani Arenstein for their assistance with this article.
 R v Alkaloids of Australia Pty Limited, Case No. 2020/00347778, and R v Christopher Kenneth Joyce, Case No. 2020/00347777 (Downing Centre Local Court, Sydney, New South Wales). Section 45AD of the CCA sets out the requirements for a cartel provision. Section 45AF makes it a criminal offence to enter into a contract, arrangement or understanding that contains a cartel provision. Section 45AG makes it a criminal offence to give effect to a cartel provision.
 Liza Carver, ACCC Commissioner, ‘Alkaloids of Australia and its former export manager sentenced in criminal price fixing cartel’, media release, 29 November 2022.
 Commonwealth Director of Public Prosecutions v Alkaloids of Australia Pty Ltd  FCA 1424 .
 Commonwealth Director of Public Prosecutions v Alkaloids of Australia Pty Ltd  FCA 1424 .
 Section 51(3) of the CCA provided a limited exemption for conditional licences or assignments of specified IP rights.
 The brand names Revlimid and Pomalyst are registered trademarks.
 See, for example, the Notice on Implementation Guidelines for Promoting the Two-Invoice System for Pharmaceutical Procurement by Public Health Institutions.
 Article 17(1) of the AML prohibits dominant undertakings from supplying products at excessive prices. Article 17(3) prohibits dominant undertakings from refusing to deal with counterparties without a reasonable justification. Article 17(5) prohibits dominant undertakings from imposing unfair trading conditions.
 Article 13 of the AML prohibits agreements among competitors to eliminate or restrict competition in the market.
 Article 14 of the AML prohibits the fixing of resale prices or setting minimum resale prices.
 The brand names Bio-Oss and Bio-Gide are registered trademarks.
 GCR, ‘China hits Swiss pharma company with RPM fine’, 1 March 2022.
 Section 3 of the Competition Act 2002 prohibits anticompetitive agreements. These cases focus on alleged contraventions of section 3(3)(b) read with section 3(1) of the Competition Act 2022.
 See the Order under section 27 issued on 30 August 2018 in M/s Alis Medical Store and Ors and Federation of Gujarat State Chemists & Druggists Associations (FGSCDA) and Ors (Case Nos. 65, 71 and 72/2014, and 68/2015) and more recent orders issued on 12 March 2020 in the cases of Shri Suprabhat Roy, Proprietor, M/s Suman Distributors v Shri Saiful Islam Biswas, District Secretary of Murshidabad District Committee of Bengal Chemists & Druggists Association and Ors (Case Nos. 36/2015, 31 and 58/2016); and on 3 June 2019 in Madhya Pradesh Chemists and Distributors Federation (MPCDF) v Madhya Pradesh Chemists and Druggist Association (MPCDA) and Ors (Case No. 64 of 2014).
 Liability was found under section 48(1) and (2) of the Competition Act 2002.
 See the Order under section 27 issued on 20 June 2019 in Mr Nadie Jauhri v Jalgaon District Medicine Dealers Association (JDMDA) (Case No. 61 of 2015).
 CCI, ‘Market Study on the Pharmaceutical Sector in India: Key Findings and Observations’,
18 November 2021.
 See the Order under section 26(2) issued on 25 October 2022 in Mr Swapan Dey v Vifor International (AG) and Vifor Pharma Management Ltd (Case No. 5 of 2022).
 Section 3(5) of the Competition Act 2002 allows the CCI to consider whether alleged anticompetitive agreements are justified to protect IP rights.
 See article 3 of Act No. 54 of 14 April 1947 on Prohibition of Private Monopolisation and Maintenance of Fair Trade, which prohibits unreasonable restraints of trade.
 See PCC Issues Paper No. 2, Series of 2020, ‘A Profile of the Philippine Pharmaceutical Industry’, Celia M Reyes and Aubrey D Tabuga, and Policy Note No. 2, Series of 2020, ‘Identifying Challenges in the Philippine Pharmaceutical Industry’, Celia M Reyes and Aubrey D Tabuga.
 PCC 2021 Year-end Report, ‘Competition in 2021: Strengthening Foundations for Inclusive Recovery and Sustained Growth’.
 See section 14(a) of the Philippine Competition Act, which prohibits price fixing.
 PCC, ‘Press Statement Re: PCC’s resolve to strengthen enforcement in the pharmaceutical sector’,
26 July 2022.
 The brand name Zoladex is a registered trademark.