The Competition and Markets Authority (CMA), the competition regulator in the UK, has undertaken a number of investigations into suspected anticompetitive practices in the pharma sector in recent years. Most recently, the CMA announced on 3 October 2019 that it has issued a Statement of Objections to pharmaceutical companies Aspen, Amilco and Tiofarma. The CMA’s provisional findings are that, in 2016, Aspen unlawfully agreed to pay (by different means to each of the companies) each of Amilco and Tiofarma to stay out of the UK market for fludrocortisone acetate 0.1mg tablets (a prescription-only medicine that thousands of patients rely on to treat primary or secondary adrenal insufficiency, commonly known as Addison’s Disease). The CMA’s investigation concerned suspected breaches of both Article 101 TFEU and Article 102 TFEU.
The CMA has provisionally found that Aspen, in order to protect and maintain its position as the sole UK supplier of fludrocortisone (thereby allowing it to increase prices by up to 1,800%), agreed to make Tiofarma the sole manufacturer of fludrocortisone for direct sale in the UK, and granted Amilco a 30% share of the increased prices that Aspen was able to charge, on condition that each of those companies stayed out of the market.
Aspen has previously admitted to participating in an anticompetitive agreement (in August 2019) and, as a result, agreed to settle the case with the CMA and pay a maximum fine of £2.1 million if the CMA reaches a formal decision that the law has been broken. The reason that the investigation remains ongoing is that the other two companies have not admitted liability.
In addition to that settlement, Aspen offered commitments to resolve a competition concern relating to its 2016 purchase of a competing fludrocortisone product from Tiofarma authorised for supply in the UK. The effect of that purchase was to bring all existing fludrocortisone marketing authorisations in the UK permanently under Aspen’s ownership.
The CMA has now issued a decision accepting Aspen’s commitments and making them binding; the commitments included the payment of the NHS £8 million (without the Government having to issue a follow-on claim for damages. The CMA was concerned that as a result of the impact of Aspen’s behaviour, the NHS paid a higher price for fludrocortisone), as well as ensuring that, in the future, there will be at least two suppliers of fludrocortisone in the UK to help the NHS access more competitive prices. This will be done by (i) Aspen divesting itself of the rights over Ambient Storage Fludrocortisone necessary to commercialise that product in the UK; and (ii) reintroducing and commercialising Cold Storage Fludrocortisone (the product that it was selling in the UK prior to March 2016) in the UK market within 12 months.