Farmatrends, win-win moet je doen!
december 17, 2009 9 reacties
Voor de jaarwisseling nog even een topicje m.b.t. Big Pharma. Of….hoe volgens een rapport uit de U.K. meer overheidsbemoeienis met en met betrekking tot de farmaceutische industrie zijn vruchten afwerpt.
We’re losing it!
Verderop nog meer kontschoppende ammunitie tegen de anti-overheidsbemoeiers m.b.t. de farmaceutische industrie.
De graph komt uit een rapport over de voortgang van het Pharmaceutical Price Regulation Scheme (PPRS) in de U.K.
The Pharmaceutial Price Regulation Scheme, Tenth Report to Parliament
Clear evidence. Overheidsbemoeienis werkt! Maar het moet wel twee kanten op werken.
• allows companies freedom of pricing for new medicines (new active substances);
• requires companies with NHS sales of more than £35 million a year to submit annual data on sales, costs, assets and profitability and to repay the excess where profits exceed the agreed threshold;
• requires companies to seek the Department’s agreement for price increases, which are only granted if the reasons for the application meet the criteria for increases set out in the agreement; and
• provides significant support for research and development (R&D), and initiatives to encourage and reward innovation.
Wat staat er in dit rapport?
• 150 companies have signed up to the new voluntary scheme, which started on 1 January 2009, and 55 companies, which have not signed up to the voluntary scheme, are subject to statutory controls under the Health Service Branded Medicines (Control of Prices and Supply of Information) (No.2) Regulations 2008.
• All companies have reduced prices by 3.9 per cent from 1 February 2009 as required under the scheme (with a further price cut of 1.9 per cent from 1 January 2010).
• The 2009 PPRS includes for the first time a package supporting innovation and the uptake of clinically and cost-effective medicines, and new measures such as more flexible pricing arrangements and more systematic use of patient access schemes aimed at ensuring that medicines better reflect their value.
• The number of scheme members submitting Annual Financial Returns (AFRs) in accordance with the agreed timetable has fallen, with almost a half of companies submitting their 2007 returns late and the average delay increasing to 41 days since the last report.
• The Department continues to have concerns about whether submitted AFRs meet the degree of transparency required by the scheme. The Department rigorously examines and questions such returns, which is why there was an increase in the average time taken to clear the 2003–2005 AFRs. A number of returns dating back to 2003 remain uncleared and the Department continues to discuss these with companies.
• A comparison of the prices of branded medicines in the UK with prices in a range of European countries and the USA and Australia shows the UK moving from among the highest in Europe in 2004 to among the lowest in Europe in 2008. The fall in value of the pound between 2004 and 2008 accounts for much of the change in the position of the UK relative to other countries over this period.
U leest het maar.
Gaan wij verder met de volgende PDF. Met dank aan Tealon op dit topic.
Omdat u er niet allemaal bij kunt vanwege een slotje, hier even het artikel in PDF. Kopiëren kan dus het mag.
This analysis shows that the rate of production of new drugs by these companies has been constant (although the rates differ for each company) since they began producing drugs. Surprisingly, nothing that companies have done in the past 60 years has affected their rates of new-drug production: whether large or small, focused on small molecules or biologics, operating in the twenty-first century or in the 1950s, companies have produced NMEs at steady rates, usually well below one per year. This characteristic raises questions about the sustainability of the industry’s R&D model, as costs per NME have soared into billions of dollars. It also challenges the rationale for major mergers and acquisitions (M&A), as none has had a detectable effect on new-drug output. Finally, it suggests that drug companies need to be bolder in redesigning their research organizations if they are to escape the increasing pressures created by linear new-drug output and rapidly rising R&D costs.
Nu even naar het ‘overheidsbemoeienis’-model. Vaak aangehaald door farmalobby’s als beperkende factor. Niets schijnt minder waar. Kijk even onder het kopje: Does regulation hinder innovation?(pag. 5)
It shows that countries with a more demanding regulatory apparatus, such as the United States and the UK, have fostered a more innovative and competitive pharmaceutical industry. This is because exacting regulatory requirements force companies to be more selective in the compounds that they aim to bring to market. Conversely, countries with more permissive systems tend to produce drugs that may be successful in their home market, but are generally not sufficiently innovative to gain widespread approval and market acceptance elsewhere. This is consistent with studies indicating that, by making research more risky, stringent regulatory requirements actually stimulate R&D investment and promote the emergence of an industry that is research intensive, innovative, dominated by few companies and profitable.
Again, lees het allemaal even.
De laatste in het drieluik der overheidsbemoeienis komt van de industrie zelf. Een aanzet tot het verschuiven van de R&D goals.
The signs of malaise are obvious. An unprecedented
number of blockbuster products are going off-patent, and despite record investments in R&D the pipeline of new drugs to replace them is decidedly thin. [….] Spending on sales and marketing in the United States, for example, has increased 13 percent a year over the past eight years, while return on that investment has dropped by 15 percent. Attempts to improve efficiencies have had limited success, and companies are having to resort to cost-cutting.
Met name de plannen van Obama voor het introduceren van zijn healthcare-plans en het betaalbaar maken hiervan (zie de kosten die de USA maakt voor medicijnen in mijn eerste plaatje) zullen, op termijn, de farmaceutische industrie nopen tot het omgooien van het roer. Voorstellen worden in dit document gedaan.
The growing importance of the payer. While the clinician makes the ultimate prescribing decision, he or she is increasingly constrained by formularies, influenced by guidelines, prompted by IT systems, and “incentivized” by financial mechanisms. These mechanisms are driven by payers and regulators or by provider organizations responding to payer costs and political pressure.
Daarom zal de wal het schip keren. De betaler bepaalt. Die wil in de toekomst niet alleen mooie RCT’s maar ook de impact van medicijngebruik op de gezondheid van de consument. Harde klinische data op harde klinische gronden.
addressing real-world health issues, and gain competitive advantage from its ability to deliver service models that create system value rather than marginal improvements in efficacy. [….]Against these new requirements, the traditional model of a globally integrated pharmaceutical industry will struggle to survive. It will be too large, unwieldy and unfocused to connect with payers, providers and potential partners in the many markets it seeks to serve. The most successful pharmaceutical companies of the future will shift from being R&D-driven to become market-driven, and this will require a complete rewiring of their organizations.
Meer bemoeienis van de overheid? Niets mis mee. Dat hoeft helemaal niet ten koste te gaan van de farmaceutische industrie. Integendeel. Het vergt slechts een aanpassing. Degenen die dit niet op tijd doen vallen ten prooi aan de betaler. Te lang focussen op kortetermijnwinsten (blockbusters) om de aandeelhouders te plezieren gaat als een vuurwerkbom op oudjaar in je gezicht ontploffen.
Noem het survival of the fittest en wie de ‘fittest’ is bepalen we zelf wel. Win-win moet je doen!