(Views do not necessarily represent TACD positions)
When “access” is not accessible, “transparency” is not transparent and “affordability” is not affordable
Last Wednesday evening at the Strasbourg plenary session many Members of the European Parliament voiced their demands for an effective European strategy for access to affordable life-saving medicines.
The debate was sparked by the outrageously abusive prices for treatments for Hepatitis C that affects 9 million Europeans. Some of the concrete proposals from liberal, green, socialist and leftist MEPs included initiatives on intellectual property rights, price capping, price transparency, new innovation models that de-link R and D costs from prices, joint procurement and competition policy.
But what was most surprising was the reaction of the European Commission and the Council represented by the Latvian Presidency of the EU. Their autistic reaction totally ignored the main objective of the debate: affordability. To understand how the European Commission and the Council of Ministers use a new language called “pharmish” I have started the following glossary. (for more technical references on please see: http://tacd-ip.org/archives/1303):
Glossary of European Commission and Council new “pharmish” terms
“Access to medicines”: Access to the market. “Timely access to market of innovative medicines”. This means shortening and simplifying the “regulatory barriers” (authorization, safety and efficacy testing, clinical trial requirements) and allowing some new very expensive medicines to be commercialized before finishing their normal regulatory evaluation afterwards through “adaptive pathways”. Here access means market access for “new” medicines not patient access for the majority of Europeans and their public health systems that cannot afford them.
“Availability”: Not available for most people. Make “available” new medicines. Give pharma EU public funds to research and develop “new, innovative medicines” (usually very expensive) with no strings attached with regards to affordability and the control over intellectual property rights. The Innovative Medicines Initiative (IMI) is one example of joint EU-Pharma initiatives (1.5 billion EU funds matched by Pharma´s opaque “in kind” contribution) that is often criticized for its lack of transparency and accountability. EU medical research funding does not set any social conditions.
“Pricing Transparency”: Only transparent for industry. No public transparency of medicine prices paid by Governments but increasing the hoops Governments must jump through to justify not buying high priced medicines or buying similar generic products instead. Tie the hands of EU member states trying to negotiate lower prices for medicines by legally mandating short deadlines for deciding prices paid to reimburse medicines. Prohibit re-assessment of efficacy and safety of medicines by EU member states.
“Differentiated prices”: Same prices but not any lower. Keeping prices from going down, less price transparency and restricting EU internal market to prevent “parallel trade”. Based on GDP to let the wealthier countries pay more for expensive medicines than poorer ones but Pharma freely establishes the first prices on the market. This is what already exists “de facto” in the EU. A strategy by the European Commission to prevent EU member states from negotiating prices that are “too low” for Pharma.
“Innovation”: Innovation is any new medicine on the market regardless of its therapeutic added value compared to existing medicines (to which they are rarely compared in clinical trials) and regardless of price. The more restrictions and delays for the entry of generic products onto the market, the more innovation. Whatever is protected by intellectual property rights, the more patents filed, the more innovation, The more market access of new products, more innovation. The longer the monopoly periods of “data exclusivity” and “supplementary patent certificates”, the more positive “innovation environment”. The lower the threshold is to qualify as “an innovative step” to justify granting a new patent monopoly, the more innovation. The less stringent regulation and authorization procedures (“barriers”) are on safety, efficacy and transparency, more innovation.
“Setting prices by health outcome”: This means justifying very high prices for new medicines on the basis of the theoretical “preventive savings” over time to a public health authorities in comparison with non-use of the medicine. This reasoning applied to other products would mean that street traffic light technology prices should take into account the cost of all the accidents if traffic lights were not installed at street corners.
“Health Technology Assessment” HTA: The evaluation of the cost-benefit analysis of new medicines before they are purchased by EU member state public health authorities. Something to be avoided, weakened and obstructed as they tend to be bad for industry growth (specially if it is independent and rigorous) . The European Commission discourages re-assessment of the therapeutic value of new medicines and is considering cutting funding for EU wide cooperation of HTAs.
“Joint Procurement”: A procedure established to centralize with the European Commission the pooling of procurement of medicines for a number of EU member states that has never been used to purchase medicines due to the lack of confidence of most EU member states in the independence from the pharmaceutical industry of the European Commission.