FAS Russia decision No. 1-11/202-11 of 25 May 2012
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A documentary investigation into the Pharmstandard–ROSTA agreement that eliminated price competition in a federal Pulmozyme procurement for a cystic-fibrosis population in which children predominated according to the nearest national registry, together with the court record and ROSTA's corporate history. Roche is identified solely as the medicine's manufacturer and was not found to be a cartel participant.
If the Russian website blocks or restricts the page from loading in your country, use the local copy hosted by GOYA Law Group.
If the Russian website blocks or restricts the page from loading in your country, use the local copy hosted by GOYA Law Group.
If the Russian website blocks or restricts the page from loading in your country, use the local copy hosted by GOYA Law Group.
On 25 May 2012, in case No. 1-11/202-11, the Russian Federal Antimonopoly Service found ROSTA CJSC and Pharmstandard OJSC in breach of the prohibition on agreements that lead or may lead to increasing, reducing or maintaining prices at tenders. The decision concerned electronic auctions for medicines procured for public needs in 2008–2009.
Two admitted bidders were supposed to compete for a public contract. One of them did not appear at the auction; the other received the contract at exactly the initial maximum price. The FAS and the courts found that this was not a coincidence but an agreement between ZAO ROSTA and OAO Pharmstandard aimed at maintaining the price.
Lot No. 16 of Auction No. 091127/001550/312 concerned dornase alfa, an inhalation solution of 2.5 mg/2.5 ml, pack of 6, marketed as Pulmozyme. According to the FAS case materials, the medicine was intended for the federal procurement of medicines for patients with cystic fibrosis under the high-cost nosologies programme. It breaks down extracellular DNA in sputum and helps improve lung function; the manufacturer’s official prescribing information expressly covers treatment in both children and adults.
On 27 November 2009, the Ministry of Health and Social Development announced a procurement of 80,448 packs at an initial maximum price of RUB 671,270,983.68. Delivery was divided into two parts: 32,180 packs, or 40%, and 48,268 packs, or 60%. On 13 January 2010, the contract was awarded to Pharmstandard at the same maximum price — with no reduction at auction.
The FAS reconstructed not a single act but a sequence of coordinated steps. Even before the auction was published, ROSTA arranged the purchase of Pulmozyme and then documented its resale to Pharmstandard in quantities that matched, down to the last pack, the future state order and its two delivery stages. Both companies subsequently submitted applications and were admitted, but ROSTA did not appear at the auction.
In the absence of a second bidder, the auction was declared unsuccessful and Pharmstandard became entitled to conclude the contract at the initial maximum price. The FAS Commission characterised the combined documentary record, the exact matching quantities, the submission of two applications without a genuine intention to compete, and one bidder’s non-appearance as an agreement aimed at maintaining the price in order to obtain maximum profit.
ROSTA explained the sale of the entire consignment by Pharmstandard’s more favourable 20% prepayment and maintained that it had submitted an application to avoid disruption of supplies. The FAS considered these explanations but found them insufficient in light of the earlier documents, the exact matching quantities and the parties’ conduct at the auction; the courts did not alter that outcome. The resale of the goods is not itself characterised as unlawful — the legal conclusion rests on the conduct taken as a whole.
On 25 May 2012, the FAS found that ZAO ROSTA and OAO Pharmstandard had infringed Article 11(1)(2) of the Law on Protection of Competition: their agreement resulted in maintaining the price at auction. The FAS identified income of RUB 670,828,519.68 for ROSTA and RUB 671,270,983.68 for Pharmstandard. These figures are the income stated by the regulator, not an automatically proven amount of overpayment from the public budget.
A turnover-based fine of RUB 201,381,295.10 was imposed on Pharmstandard. After the first judicial decisions were set aside and the matter was reconsidered, the company lost at first instance, on appeal and in cassation. On 18 February 2016, in Case No. 305-AD14-3104, the Supreme Court left those judgments unchanged and dismissed the complaint. The public materials establish the obligation arising from the fine, but do not by themselves prove that it was actually paid. Nor do they establish the criminal guilt of any person.
ROSTA was not a chance technical bidder. Industry accounts trace its creation in 2002 to the combination of the distributors Farm Tamda 77, Rossib Pharmacia and ArthroMed. The official history of the Finnish company Tamro confirms that in 2002 it acquired a stake in a new nationwide Russian wholesale distributor; Tamro’s holding increased to 42.5% in 2006 and was sold in 2010.
Even after the FAS case, the group remained a major market participant: in RNC Pharma’s rankings for 2014 and 2015, ROSTA was Russia’s third-largest pharmaceutical distributor, with shares of direct supplies of 13.1% and 12.0%, respectively. In 2017, the group sold the Raduga and Pervaya Pomoshch pharmacy chains to Erkapharm.
On 23 January 2018, in Case No. A41-79022/2017, supervision proceedings were commenced against the same legal entity (Primary State Registration Number, OGRN 1027726007561); on 31 January 2019, AO ROSTA was declared bankrupt and liquidation proceedings were opened. Fedresurs continues to show its bankruptcy status. These later events matter to the company’s corporate history, but it has not been established that the bankruptcy resulted from the cartel case; this article draws no such causal connection.
A cartel in an ordinary procurement already deprives the contracting authority of a genuine choice. A cartel concerning a medicine for a serious hereditary disease adds a different moral dimension: competition here should convert a limited budget into the greatest possible amount of treatment for vulnerable patients, a substantial proportion of whom were children.
We do not claim that a particular child failed to receive the medicine because of this agreement: the public materials do not prove that, and the competitive price that would have emerged without collusion is unknown. But the economic logic is clear and is expressly identified as an inference: when the price is held at the maximum, the state loses the opportunity to direct any potential saving towards additional treatment courses, diagnostics or other patient needs.
The moral problem therefore cannot be reduced to the amount of the fine. As the FAS established, the participants created the appearance of two independent bids where the state expected genuine competition. Turning publicly guaranteed assistance for patients — predominantly children — into a source of maximum profit insulated from price competition is an abuse of public trust. This is an editorial assessment based on the established mechanism and context, not a separate finding of the court.
Primary documents are listed first; industry publications are used only for corporate history and rankings.
The text below is an editorial translation of the core legal content. It makes the case readable in every site language, but does not replace the Russian original and is not a certified translation.
FAS found ROSTA and Pharmstandard parties to a prohibited agreement in public procurement of medicines.
Pharmstandard received a turnover-based fine of RUB 201,381,295.10; FAS later reported more than RUB 402m combined for both participants.
The Moscow District commercial court set aside the initial judgments that had annulled the fine order.
On reconsideration in case No. A40-142261/2012, the application to annul the FAS fine order was dismissed.
The appellate and district cassation courts upheld the dismissal; Pharmstandard’s subsequent Supreme Court complaint did not alter the result.
Full Russian text of the competition-law infringement decision.
The official case file contains the first-instance, appellate and cassation acts concerning the challenge to the FAS fine.
This official FAS publication compares the case with other major cartel proceedings.
The public Pharmstandard archive for 2007–2026 and its current Business Development page were reviewed. That page names 15 international partners but does not disclose the subject, date and duration of every agreement. Pharmstandard’s claim, an archived agreement and current counterparty confirmation are therefore shown separately. A current independent relationship is established for Sanofi and Roche; for the others, current status rests only on Pharmstandard’s list or is confirmed historically. Roche was not a cartel participant.
Current relationship independently confirmed
In June 2025 Pharmstandard reported a GENERIUM–Sanofi agreement for full-cycle production of insulin glargine 300 U/ml. Sanofi separately publishes a commercial policy, updated on 23 January 2026, governing its agency agreement with Pharmstandard. This is the strongest public evidence of a continuing relationship.
Current relationship independently confirmed
Pharmstandard’s archive documents a strategic partnership and full-cycle localisation of Gazyva. Roche Moscow’s current page separately lists Pharmstandard as a distributor. Roche was not a party to the cartel case and is mentioned here only as a separate counterparty and the manufacturer of Pulmozyme.
Named a partner by Pharmstandard in 2026
Pharmstandard reports a 2013 agreement and localisation of secondary packaging for Synagis from 2014, and again names AbbVie as a partner in 2026. No independent public confirmation of the current product agreement was found.
Named a partner by Pharmstandard in 2026
The 2017 agreement covered technology transfer, manufacture, commercialisation and promotion of blinatumomab for seven years with an extension option. Pharmstandard names Amgen as a partner in 2026; Amgen has not published confirmation that this specific agreement was extended.
Named a partner by Pharmstandard in 2026
Pharmstandard names AstraZeneca on its current business-development page but discloses no subject, date or duration of an agreement. A joint 2024 compliance marathon does not itself prove a product contract; no independent confirmation of a current agreement was found.
Named a partner by Pharmstandard in 2026
Chiesi’s 2013 annual report confirms an agreement concerning Foster, while Pharmstandard includes Chiesi in its 2026 partner list. No public confirmation by Chiesi that the specific agreement continues in 2026 was found.
Named a partner by Pharmstandard in 2026
Eisai confirmed agreements to localise Halaven, Lenvima and Fycompa in 2016; Pharmstandard also names Eisai as a partner in 2026. The scope and continuation of the agreement at the current date are not publicly confirmed by the counterparty.
Named a partner by Pharmstandard in 2026
Pharmstandard reported a strategic partnership and full-cycle manufacture of Tractocile and Pabal at UfaVITA, and continues to name Ferring as a partner in 2026. No independent confirmation of the project’s current scope was found.
Named a partner by Pharmstandard in 2026
Pharmstandard’s archive records manufacturing and licensing arrangements for HIV, hepatitis C and COVID-19 medicines, including Sovaldi, Truvada, Epclusa, Biktarvy and Veklury. Gilead appears in the 2026 list, but the current scope of the agreements is not independently confirmed.
Named a partner by Pharmstandard in 2026
Both parties’ documents confirm licensing of Sirturo, technology transfer and contract manufacture for export; Velcade had been localised earlier. Pharmstandard names “Johnson, RUSSIA” in 2026, but J&J does not confirm the current status of the specific agreements.
Named a partner by Pharmstandard in 2026
J&J confirmed a memorandum and agreement to localise OneTouch test strips; Pharmstandard reported full transfer in 2020 and includes LifeScan Russia in its 2026 list. Since LifeScan became independent, no independent confirmation of the current relationship was found.
Named a partner by Pharmstandard in 2026
The agreements concerned manufacture, distribution and marketing of Rebif; an official Merck publication confirms local fill-and-finish. Pharmstandard names Merck Russia in 2026, but the project’s current status is not established. This is Germany’s Merck KGaA, not US-based MSD/Merck & Co.
Named a partner by Pharmstandard in 2026
Pharmstandard includes Novartis Pharma in its 2026 partner list. The archive records Tasigna sales but does not disclose an agreement, its date or scope; the counterparty has not confirmed a current relationship in the public materials reviewed.
Named a partner by Pharmstandard in 2026
The 2020 agreement covered technology transfer and contract manufacture of four oncology medicines; Pharmstandard published updates in 2023–2024 and names Pfizer in 2026. Pfizer’s adviser Clifford Chance independently confirms the transaction, but not its present performance.
Named a partner by Pharmstandard in 2026
Pharmstandard reports localisation and technology transfer for ADCETRIS and includes Takeda Russia in its 2026 list. Takeda is Japanese, not Western, and is shown separately for completeness of the official international list. The current scope is not independently confirmed.
Named a partner by Pharmstandard in 2026
Zentiva Pharma is named on Pharmstandard’s current partner page. The reviewed public record contains no disclosed subject, date or duration of an agreement and no independent confirmation by the counterparty.
These Western and borderline international relationships appear in the archive but are absent from the current 2026 list or require separate classification.
Historical agreement confirmed; current status not established
A Product Licence and Manufacturing Agreement for Imudon and IRS 19 covered imported compounds, local formulation, filling and packaging, a planned full cycle and an option over IP, know-how and trademarks.
Historical agreement confirmed; current status not established
Exclusive distribution and promotion of Mildronate accompanied Pharmstandard’s acquisition of 11.3% of Grindeks; the stake was sold in October 2010. This is a historical, not proven current, relationship.
Current relationship independently confirmed
The 75/25 Pharmstandard-Medtechnika joint venture was created for infection-control equipment and technology transfer. The subsidiary’s current website continues to describe itself as DGM’s official supplier. This concerns medical technology, not medicines.
Historical agreement confirmed; current status not established
An agreement among Pharmstandard, Nacimbio and Kedrion created Kirov Plasma for full-cycle plasma-derived medicines. A 2023 release confirmed supply of an Italian intermediate product, but the agreement’s precise current term is undisclosed.
Historical agreement confirmed; current status not established
Pharmstandard reported localisation of Celgene’s Revlimid in 2017 and BMS’s transfer of rights to Daklinza in 2019, including the marketing authorisation, IP, a temporary brand licence and technology transfer. BMS is absent from the current 2026 list.
Historical agreement confirmed; current status not established
A research, development and licensing agreement for two antibodies was concluded through the joint subsidiary NTS Plus, with Pharmstandard to commercialise the products in Russia and the CIS. A Viktor Kharitonin vehicle simultaneously invested in Affitech; this must be distinguished from a direct Pharmstandard agreement.
Borderline corporate relationship
The agreement to manufacture, promote and distribute Mikrazim, Filtrum, Laktofiltrum and Ursogliv was made with Russia’s AVVA Rus; the page links it to Switzerland’s AVVA Pharmaceuticals AG. It is therefore classified as borderline rather than a straightforward Western-company agreement.
The factors below are evidence-based institutional explanations and analytical hypotheses, not established motives of particular companies. A final conclusion would require non-public due-diligence, audit and agreement-approval records.
Pharmstandard itself offers registration, launch, market access, sales, distribution, localisation, serialisation, pharmacovigilance and medical services. For an originator, that can reduce the number of contractors and time to market.
OpenThe agreements repeatedly use one model: the Western company provides the product, rights, compound or know-how, while Pharmstandard supplies the site, packaging, quality control, registration and commercial infrastructure. This is the documented transaction structure, not proof of an improper motive.
OpenAfter technology transfer, site registration and commercial batches, replacing a manufacturer may require new validation, regulatory work and investment. Continuing or winding down a project under controls may therefore be more rational than immediate termination, especially for essential medicines. This is an analytical hypothesis; the decisions of particular boards are not public.
OpenThe FAS decision and final fine are material adverse-media and antitrust factors. Yet the reviewed partner codes require assessment, controls and fair competition, not universal lifetime termination of every agreement. Partners may have treated the risk as manageable; without questionnaires, audits and committee decisions, that remains a hypothesis.
OpenPharmstandard says its partnering process includes critical risk factors, compliance and master-agreement approval. None of the reviewed publications discloses whether partners were told of case No. 1-11/202-11, what remediation they required or who approved continuation. Those documents are necessary for an evidential answer to “why”.
OpenArticle 11 of Law No. 135-FZ prohibits cartels; turnover-based administrative fines and, where the criminal elements are met, liability under Criminal Code article 178 may follow.
OpenArticle 101 TFEU prohibits cartels; a European Commission fine may reach 10% of the group’s total annual turnover.
OpenAlongside corporate sanctions, individuals may face the criminal cartel offence: up to five years’ imprisonment and an unlimited fine.
OpenAgreements among competitors to fix prices, allocate markets or rig bids are criminal Sherman Act violations, carrying major fines and imprisonment.
OpenWas FAS decision No. 1-11/202-11 considered in the initial and periodic due diligence of Pharmstandard?
What remediation, assurances and audit mechanisms were required from the Russian counterparty?
Who within each group approved continuation of the relationship, and on what documented risk assessment?
How do the partners currently test competition compliance in essential-medicine supply and public procurement?
Boundary of the conclusion: the historical infringement was established by FAS and judicially reviewed. It does not automatically prove a new infringement, Pharmstandard’s current motive or wrongdoing by its partners. Any new episode requires a separate investigation and evidence.