Aspen’s response to Guardian article : 28 January 2017

30/01/17: Shauneen Beukes

Durban - It is important to respond to the issues raised pertaining to Aspen in the article published in the Guardian on Saturday, 28 January 2017 under the title 'Drugs firms are accused of putting cancer patients at risk over price hikes' (https://www.theguardian.com/society/2017/jan/28/nhs-drug-firms-cancer-patients-at-risk-prices-inflated) in a balanced manner and in so doing give context to the allegations made.

• The mentioned pricing for Aspen's products is, in real terms, low and just a fraction of the alternate treatments in each of the particular therapeutic classes. The average price per tablet of the Aspen products is below £2 and the average price per bottle of 25 tablets is below £50. This is a demonstration of Aspen's commitment to ensuring the supply of these extremely complex products, both affordably and at the highest quality. While the percentage increases in respect of the Aspen products, when considered in isolation, appear to be substantial, these increases are from a very low and unsustainable price base, having not been increased over decades.

• Busulphan is raised as the highest percentage price increase. Total sales in the UK at this higher pricing are about £15,000 per month. This will neither put pressure on any healthcare budget nor benefit any share price. The revenue from these sales hardly covers the costs of the regulatory infrastructure, fees for pharmacovigilance, let alone the increasing requirements demanded by regulators including new analytical method development, need for improved and specialist contained manufacture and numerous additional reporting requirements.

• Aspen has never failed to supply product when it is available. We do acknowledge supply shortages of one of our products. We have been continuously addressing this supply shortage and are trying to improve supply globally. To suggest supply has been withheld is simply factually incorrect and bordering on mischievous. The Health Care Regulators are aware of the supply challenges and are working with Aspen to expand supply sources.

• It is confusing to suggest that generic drugs can be manufactured for less than the cost of the raw materials. This would be commercially unsustainable as it implies the generic drugs would be sold at below cost?

• The facts above are equally applicable to the Italian Competition Authority ('ICA') matter reported in October 2016. The products in question had not undergone any price increases in Italy for more than fifty years prior to the increase that had been negotiated with the Italian Health Authorities. The weighted average price for a pack of 25 tablets of each of the four products concerned in this matter is now in the order of €2 per tablet, also constituting a fraction of the cost of alternate treatments in each of the particular therapeutic classes.

• Based on legal advice received, the ICA's decision has been appealed to an independent and competent court in Italy on the grounds that the finding is materially flawed from both a procedural and substantive perspective. Aspen remains confident that it will be awarded a full annulment of the ICA's decision in terms of this appeal.

• Aspen pricing was not set arbitrarily. In most countries, Aspen cannot set pricing without regulatory approval. In many European countries, a transparent understanding of factors considered in arriving at proposed prices was demanded by the regulators. Based on these investigations, pricing was agreed and approved by the regulator concerned.

In order to achieve a consistent supply of life saving medication, it is important that the detail is thoroughly understood and all relevant factors are properly and fairly considered. This will avoid sensationalising important issues. We trust that the above response will help clarify the issues raised and assist in achieving balanced and fair reporting.
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