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Biotech and generics will benefit

The US Healthcare budget has placed a very balanced situation for the growth of both the clinical development and the generics market. The companies which are having big stakes in clinical development through licensing strategies are Big Pharma and Biotech. These companies have heavily been in a lobbying exercise with the federal government especially in the 4th quarter. The biotech companies will be undoubtedly heave a sigh of relief as the patent exclusivity period for the bio tech products to be become bio similar/ bio generics has now been extended to 12 years.

Further the concept of outsourcing clinical trials to India particularly Phase II onwards will definitely boost the growth of the Indian Clinical Trial industry with a double digit growth.

The domestic generic drug industry in the USA will have to outsource its bio –equivalence studies to cost effective geographic locations like India in order to markets its drug. Further, the generic drug companies will have to have patent litigations from non US based companies' particularly Indian Pharma companies. As the ban on out of the court settlements between branded drug manufacturer and generic drug manufacturer has not been implemented despite rigorous recommendations from the FTC (Federal Trade Commission). This will certainly help the export growth of non US based companies particularly Indian Pharma.

The only hindrance is that the US FDA should place "pathways" that would speed up the ANDA approvals.

Pricing Policy shift

It's been a week since the Obama government released the Healthcare budget. The US $911 billion was aimed at providing optimum healthcare insurance to the maximum possible. This can be made possible if cost effective medicines i.e. off patent and bioequivalent generic medicines are made available to the masses.

Subsequent to the release of the US healthcare budget which has emerged as one of the Top 3 Twitter trends in the last week, a decision to provide the lowest costing medicines to the masses in Germany has come as a part of the Germany Drug pricing policy.

The policy aims at not allowing drug makers particularly branded drug makers to decide upon the pricing negotiations of drugs between them and the wholesalers in the region.

Spending on medicines by public insurers, which cover more than 70 million of the country's population, climbed 5.3 percent to 32 billion euros last year as companies increased their prices for patent-protected medicines by 8.9 percent.

The government will ensure that pharmaceutical companies will no longer be able to set the prices for medicine one-sidedly and on their own. Drug makers will also have to provide a dossier proving why their medicines are better for patients that will form the basis for price negotiations with health insurers. The payers may impose mandatory rebates of as much as 16 percent after the first 12 months, according to the plan.

The government aims to set a maximum price for medicines if drug makers and insurers fail to agree on an amount within a year, and the drugs would undergo a cost-benefit analysis by the Institute for Quality and Efficiency in Health Care, a semi-state body that includes doctors and known as IQWiG.

This is likely to change the face of German drug market because all those drug makers with a non-German origin will have to compulsorily bend to negotiating in a more aggressive manner with the payers.

Likely to be beneficial

The US Healthcare Bill-

The passage of the US healthcare reform bill has highlighted the global generic opportunity.

The aim of the US Healthcare Bill

The passage of the US healthcare reform bill, which aims at reducing healthcare costs, will help Indian companies which are among the lowest cost producers of generic drugs.

The Impact of the US Healthcare Bill

The reform bill which has recently been passed into law in the US has two key features. It increases health coverage and aims at the reduction in healthcare costs. The bill increases the coverage to an additional 32 million uninsured Americans who make up about 10 per cent of the total US population. The bill prohibits insurance companies from excluding people with pre-existing medical conditions and dropping policy holders on account of coverage limits.

Secondly, the bill which is expected to cost US taxpayers $940 billion over the next decade is expected to reduce the US fiscal deficit by $143 billion. Among the other provisions which is of interest to Indian companies is the inclusion of a 75 per cent discount on generic drugs bought through Medicare (health insurance for senior citizens) and the fact that the bill did not ban patent settlement deals between innovators and generics players helping Indian generic firms which agree to delay their launches and negotiate an out of court settlement.