Pharmacies

Interview with Fred Roeder, an overview of the European medication Market

European elections 2019: science at the polls

In the context of the European elections, European Scientist is bringing you an overview of experts from different countries on various topics around science and science policy in Europe, in order to provide a panorama and analysis, which will be useful for the next commission.

The Europeans Scientist: What does the European medication Market looks like at the moment? How about the regulation?

After the United States, Europe is the most important and innovative region for pharmaceutical breakthroughs. Five out of ten of the world’s largest pharmaceutical companies are based in Europe (though only two of them in the EU after Brexit). The regulation and access to medicines in Europe is partially regulated by the EU and partially by Member States. To understand this better it’s important to distinct between mere market authorization, which allows a drug manufacturer to sell its product in a country and pricing and reimbursement decisions which determine the price of the drug and whether the public health insurance covers it.

Market access decisions are either made by the EU or at least regulated uniformly. While the European Medicines Agency (EMA) is currently busy with moving from London to Amsterdam, it has also a central role in the medicines approval system within the EU, Iceland, Liechtenstein, and Norway. If a pharmaceutical company seeks marketing authorization for an innovative drug in even just one EU Member State it has (in most cases) to apply centrally at the EMA for a marketing authorization. Generics and other medicines can be approved by national medicines agencies through either a decentralized method or by mutual recognition of existing marketing approvals in other Member States.

The decision on how much a pharmaceutical company, a wholesaler, and pharmacies can actually charge for drugs is made on either member state level or even on lower regional levels. Traditionally wealthier countries pay higher prices for drugs and cover more innovative medicine than less wealthy member states. There has been recently a push by Italy and also the World Health Organization to bring price controls on to a supranational level. Several EU countries already collaborate in the hope to have a higher bargaining power against pharmaceutical companies in the price negotiations.

ES: Is there a model to follow? Do you recommend more regulation and harmonisation or do you think that each state should keep its difference?

Different numbers show that innovative pharmaceutical companies make over 50% of their global profits in the United States. This has historically allowed Europe to have lower drug prices than the US. The current aggressive moves to bring drug prices even further down in several EU countries might severely harm the future pipeline for innovation in Europe. As a patient I am of course interested in cost control but I am even more interested in new drugs that are able to cure diseases we currently can’t treat. Many politicians run a populist train of cutting profits for pharmaceutical companies. This sounds first sexy but might jeopardize future scientific breakthroughs.

ES: What are your recommendations for the next Commission?

During the stalled TTIP talks there were good idea about more regulatory harmonization between the US FDA and Europe’s EMA. It would be good if the next Commission picks up these conversations and pushes for mutually recognizing market approvals of FDA and EMA. This would put both regulators under competitive pressure: Drug companies would seek approval first at the regulator that promises a better market approval process. Patients in this jurisdiction would benefit from life-saving innovative drugs being earlier available. Another important area were we still need improvements is to allow more patients to have access to potentially life-saving drugs that have not been approved by regulators yet. This is called compassionate use – One of these programs got recently approved in the United States and is called Right to Try. A terminally ill patient should have the right to try experimental (and potential unsafe) medicine if there’s a chance that this drug would save his or her life.  At the same time the Commission should refrain from pushing for unified drug prices in the EU.

Right now less affluent Member States benefit from high drug prices in the ‘North’. If there’s regulatory push to bring drug prices down to the smallest common denominator we risk that some innovative medicines companies just pull out of Europe entirely or massively delay the launch of their drugs in Europe.

Fred Roeder is a Health Economist and Managing Director of the Consumer Choice Center

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Liberals want to build their campaign around pharmacare, but ignore where drugs would end up

Fred Roeder is a health economist and the managing director of the Consumer Choice Center. David Clement is the North American-affairs manager for the Consumer Choice Center.

Internal documents from within the Liberal Party recently showed that Ontario Liberal MPs want 2019’s election campaign to be built on a national pharmacare plan.

Specifically, the proposed plan would seek to centralize and consolidate the 46 drug-procurement programs that exist in Canada. The goal would be to give Canada as a whole more bargaining power in the drug-procurement process, which would potentially lower the prices Canadians pay for their medicine. Although pharmacare could lower drug prices in the short run, it could also run the risk of exacerbating Canada’s existing drug shortage, and significantly limit patient access in the long run.

If a national pharmacare plan were to work, as advertised, it would help Canadian patients by lowering the price they pay for medicine. Unfortunately, the Liberals are largely ignoring the issue of where much of these low-priced drugs would end up, which is the United States. It is one thing to lower drug prices for Canadians, but that benefit isn’t realized if Canadian patients never actually have access to those cheaper drugs.

Pharmacare would be an attempt to further control the price of drugs. The problem is that Canada already has price-control mechanisms for prescription drugs at the federal and provincial level. Those price controls lead to much lower drug prices compared with the prices paid south of the border. That said, because Canadian drugs are cheaper than in the United States, several U.S. states have begun looking at importing pharmaceutical products from Canada in an attempt to undercut U.S. prices. For example, the Republican Governor of Florida has recently pushed for federal approval for drug importation from Canada, and U.S. President Donald Trump has already signalled his support of this measure.

And while importation from Canada to the United States could mean lower drug prices for patients in Florida, Canadian patients could suffer as a result of worsening access. U.S. Health Secretary Alex Azar has publicly stated that Canada doesn’t have the appropriate supply to meet patient demand, and that large pharmaceutical companies are unlikely to increase their supply for the Canadian market. Worsening drug shortages are the most likely outcome for Canadians if the federal government adds in more price controls while having large-scale drug exports to the United States. We know that this is the probable outcome because Canada already suffers from a lack of supply, and another measure to intervene on pricing will simply increase the incentive for American states to import from Canada.

Supply is one problem for Canadian patients, but it isn’t the only issue they face, and it isn’t the only issue that could get worse as a result of pharmacare. In addition to poor supply, Canada is significantly lagging in terms of access to potentially life-saving and innovative medicines. Countries such as Germany, Japan and the United States all introduce, and reimburse for, innovative drugs quicker than in Canada. Here, it takes more than 450 days for a new drug to be reimbursable, while that number is only 180 days in the United States. It can be expected that a pharmacare plan would make this innovation problem worse. It is unlikely that the manufacturers of these drugs will want to roll out innovative medicines in Canada, under various forms of price control, if those drugs can then be resold into other markets, undercutting prices abroad.

For cost, it is important to remember that Canadians have lower drug prices than Americans. At the same time, it is important to be aware that because of price controls, Canada is not a significant market for drug manufacturers, especially when compared with the United States, which accounts for more than 50 per cent of the industry’s global profits. If Canada goes too bullish against drug prices, while at the same time allowing American states to import prescription drugs from Canada, we might run the risk of drug companies leaving entirely, or massively delaying the introduction of new drugs in Canada.

Companies leaving the domestic market entirely might sound like a far-fetched concept, but it is something the Canadian marketplace has seen in other industries. Take Google and the recent issue of political advertising in Canada. Ottawa significantly changed its election advertising regulations, and rather than comply, Google decided that it would leave the political advertising market altogether. Thus, we have a large multinational entity cutting itself out of the political advertising market because conditions aren’t ideal, and because Canada’s market is minuscule in comparison to others.

Everyone wants more competitive and better pricing for patients. Unfortunately, the elephant in the room is where these price-controlled drugs end up, and how industry will respond. Our concern, as a consumer group, is that the pharmacare plan, without addressing export, could exacerbate the already serious issue of drug availability in Canada.

If a provider of vital pharmaceuticals were to pull out of the Canadian market as a result of price fixing and undercutting, it would be Canadian patients who pay the ultimate price. Drug access – especially to new innovative treatments – lags in Canada, and without the foresight to correct some of these blind spots, access could either get significantly worse, or be eliminated altogether under a national pharmacare plan. That scenario should concern all Canadians.

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