Price Negotiation for Patented Drugs: Still Continues A Policy Paralysis

Price Negotiation for Patented Drugs: Still Continues A Policy Paralysis

Many poor and even middle-income patients, who spend their entire life savings for treatment of life-threatening ailments, such as, cancer, have been virtually priced out of the access to patented new drugs, across the world. As articulated by the American Society of Clinical Oncology in 2014, prices of these medicines are increasingly getting disconnected from the actual therapeutic value of these products.

The plight of such patients is worse in India, and would continue to be so, as there is not even a remote possibility of Universal Health Care/Coverage (UHC) visible anywhere near the healthcare horizon of the country.

There is no recent worthwhile Government action either, to give shape to its an important decision on this issue, in a meaningful way. That critical decision was also scripted in Para 4.XV of the National Pharmaceutical Pricing Policy 2012 (NPPP 2012), and was notified on December 07, 2012. On ‘Patented Drugs Pricing’, it categorically states as follows:

“There is a separate committee constituted by the Government Order dated February 01, 2007 for finalizing the pricing of Patented Drugs, and decisions on pricing of patented Drugs would be based on the recommendation of this committee.”

Just a couple of months after, on February 21, 2013, the Department of Pharmaceuticals (DoP) in a communication to the stakeholders announced that the committee to examine the issues of ‘Price Negotiations for Patented Drugs’ has since submitted its report to the Department. Simultaneously the stakeholders were requested to provide comments on the same urgently, latest by March 31, 2013.

Following this long overdue report, lack of any worthwhile action, both by the previous and the current Governments, possibly coming under a strong pressure of the self-serving interests of the constituents of ‘Big Pharma’ and their trade associations, is indeed glaring. I shall dwell on that in this article.

A brief recapitulation:

As stated earlier, almost a decade ago, an expert committee was constituted by the Government to suggest a system that could be used for price negotiation of patented medicines and medical devices ‘before their marketing approval in India’.

This committee reportedly had 20 meetings in two rounds, where the viewpoints of the pharmaceutical industry, including large multi-industry trade bodies like - FICCI, various NGOs and other stakeholders were taken into consideration. Simultaneously, it had commissioned a study of the Rajiv Gandhi School of Intellectual Property Law and Indian Institute of Technology (IIT), Kharagpur to ascertain various mechanisms of price control of patented drugs in many countries, across the world, for independent research based inputs for this report.

Salient features of the report:

The salient features of this expert committee report were as follows:

Scope of recommendations:

The Committee in its final report recommends price negotiations for Patented Drugs only towards:

• The Government procurement/reimbursement
• Health Insurance Coverage by Insurance Companies

Issues to remain unresolved despite price negotiation:

In the report, the Committee expressed the following view:

Even after calibrating the prices based on Gross National Income with Purchasing Power Parity of the countries, where there are robust public health policies with the governments having strong bargaining power in price negotiation, the prices of patented medicines will remain unaffordable to a very large section of the population of India. Such countries were identified in the report as UK, Canada, France, Australia and New Zealand.

Thus, the government should extend Health Insurance Scheme, covering all prescription medicines, to all those citizens of the country who are not benefitting under any other insurance/reimbursement plan.

Three categories of Patented Drugs identified:

The committee identified three categories of patented drugs, as follows:

• A totally new class of drug with no therapeutic equivalence
• A drug that has therapeutic equivalence, but also has a therapeutic edge over the existing ones
• A drug that has similar therapeutic effectiveness compared to the existing one

It recommended that these three categories of Patented Drugs would require to be treated differently while fixing the price.

The Apex body for ‘Patented Drugs Price Negotiation’: 

The Report recommends a committee named as ‘Pricing Committee for Patented Drugs (PCPD)’ headed by the Chairman of National Pharmaceutical Pricing Authority (NPPA) to negotiate all prices of patented medicines.

As CGHS, Railways, Defense Services and other Public/Private institutions cover around 23 percent of total healthcare expenditure, the members of the committee could be invited from the Railways, DGHS, DCGI, Ministry of Finance and Representatives of top 5 health insurance companies in terms of the number of beneficiaries.

Recommended pricing methodology:

For ‘Price Negotiation of Patented Drugs’, the report recommends following methodologies for each of the three categories, as mentioned earlier:

1. For Medicines having no therapeutic equivalence in India:

• The innovator company will submit to the PCPD the details of Government procurement prices in the UK, Canada, France, Australia and New Zealand for the respective Patented Drugs.

• In the event of the concerned company not launching the said Patented Drug in any of those reference countries, the company will require to furnish the same details only for those countries where the product has been launched.

• The PCPD will then take into consideration the ratio of the per capita income of a particular country to the per capita income of India.

• The prices of the Patented Drug would be worked out in India by dividing the price of the medicine in a particular country by this ratio and the lowest of these prices would be taken for negotiation for further price reduction.

The same methodology would be applicable to medical devices also and all the patented medicines introduced in India after 2005.

2. For medicines having a therapeutic equivalent in India:

• If a therapeutically equivalent medicine exists for the Patented Drug, with better or similar efficacy, PCPD may consider the treatment cost for the disease using the new drug and fix the Patented Drug price accordingly.

• PCPD may adopt the methodology of reference pricing as stated above to ensure that the cost of treatment of the Patented Drug does not increase as compared to the cost of treatment with existing equivalent medicine.

3. For medicines introduced first time in India itself:

• PCPD will fix the price of such drugs, which are new in the class and no therapeutic equivalence is available, by taking various factors into consideration like cost involved, risk factors and any other factors of relevance.

• PCPD may discuss various input costs with the manufacturer asking for documenting evidence.

This process may be complex. However, the report indicates, since the number of medicines discovered and developed in India will not be many, the number of such cases would also be limited.

Negotiated prices will be subject to revision:

The report clearly indicates that ‘the prices of Patented drugs so fixed will be subjected to revision either periodically or if felt necessary by the manufacturer or the regulator as the case may be.’

Support from the domestic Indian Pharmaceutical Industry:

Pharma MNCs reportedly said that ‘Price Negotiations for Patented Products’ should be made only for Government purchases and not be linked with ‘Regulatory Approval’. They also expressed their serious concern on the methodology of ‘Patented Products Pricing’. Nevertheless, from the domestic Indian Pharmaceutical Industry, such as, Indian Pharmaceutical Alliance (IPA), Indian Drug Manufacturer Association (IDMA), Pharmexcil, Federation of Pharma Entrepreneurs (FOPE) and Confederation of Indian Pharmaceutical Industry (CIPI), there emerged strong voices of support for this Government initiative

DIPP expressed apprehensions: .............

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Even Smaller Countries Now Question Indian Drug Quality Standard

Even Smaller Countries Now Question Indian Drug Quality Standard

India has over 135 US-FDA approved pharmaceutical manufacturing units, at present. This number is very significant ranking second behind the United States, and was driving the growth of generic drug exports in the top pharma market of the world. Riding on the wave of such stellar progress, a hubris seems to have set in the related operational areas of many Indian pharma players, especially the drug exporters.

This incredible ride continued, until a first major jolt shook all concerned in this business. It came first in the form of an unprecedented hefty fine for wrong doing, followed by the US- FDA ‘import bans’ of several drugs, manufactured around 44 different Indian drug-making facilities, since over the last five years.

The first major jolt:

Not so long ago, just in 2013, quality related concerns with generic drugs exported from India came to the fore, after Ranbaxy reportedly pleaded guilty and paid a hefty fine of US$ 500 million for falsifying clinical data and distributing ‘adulterated medicines’ in the United States.

Thereafter, US-FDA banned drug imports from Ranbaxy and Wockhardt, manufactured in all those facilities that failed to conform to its cGMP quality standards.

Those are the stories for generic formulations. It then covered the Active Pharmaceutical Ingredients (API) too. On January 23, 2014, USFDA notified Ranbaxy Laboratories, that it is prohibited from manufacturing and distributing APIs from its another Indian manufacturing facility in Toansa. With this step, erstwhile Ranbaxy had virtually no access to the top pharmaceutical market of the world.

Was it for raising the bar of quality norms?

Many of us felt and expressed that ‘import bans’ of Indian drugs due to failing quality parameters, manufactured in certain facilities of largely Indian pharma companies, are mostly due to higher stringent quality norms of the US-FDA, the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA). Nevertheless, this argument does not carry much weight, as an exporter will always have to conform to the set quality standards of the importers, whatever these are. 

Indian drug regulator too made a much avoidable remark:

Unfortunately, amid such a scenario, instead of taking appropriate transparent and stringent measures, the Drug Controller General of India (DCGI) was quoted by the media saying, “We don’t recognize and are not bound by what the US is doing and is inspecting. The FDA may regulate its country, but it can’t regulate India on how India has to behave or how to deliver.”

The DCGI made this comment as the then US-FDA Commissioner Margaret Hamburg was wrapping up her a weeklong maiden trip to India, in the wake of several ‘Import Bans’ arising out of repeated cGMP violations by some large domestic generic drug manufacturers. Whereas, Hamburg reiterated the need for the domestic drug manufacturers conform to the USFDA quality standards ensuring health and safety for American patients, the DCGI’s above comment appears rather arrogant, out of tune, and was avoidable, to say the least. Instead, some serious corrective regulatory measures should have followed.

On the above comments of the DCGI, the American Enterprise Institute reportedlyreacted by saying, “Indian drug regulator is seen as corrupt and colliding with pharma companies…”.

Smaller countries initiated similar action:

It now appears that this situation is going from bad to worse and malady is much deeper. Smaller countries, such as Vietnam, have recently banned products of a sizable number of domestic pharma exporters.

On September 5, 2016, a leading business daily of India reported: “Close on the heels of Prime Minister Narendra Modi’s visit to Vietnam to strengthen bilateral ties, including defense, security and trade, the ministry of commerce and industries is planning to set up a committee, along with the Central Drugs Standard Control Organization (CDSCO), to inspect Indian pharmaceutical companies which have been banned from Vietnam for exporting sub-standard drugs.”

In 2014, the Drug Regulatory Authority of Vietnam ‘red-listed’ about 50 pharma companies for alleged regulatory non-compliance in their manufacturing practices. The names included, some big names of Indian pharma industry.

Overall pharma market size of Vietnam is estimated over US$ 2 billion, and expected to grow to US$ 8 billion by 2020. A significant chunk of Vietnam’s pharmaceutical market comprises of generic drugs, where India used to be a major exporter. In the recent years, however, Indian pharmaceutical product exports to Vietnamese market have dipped considerably, reflecting the effects of the ban, with exports declining by 12 percent to US$ 146 million in 2015-16 from US$ 165 million in the previous fiscal year, the report said.

It was envisaged, especially after the Prime Minister’s visit to Vietnam, this situation will improve notably. However, just as what happened with the USFDA on related issues, there has been no change in the overall situation in this case, either.

Further, on November 23, 2016, yet another Indian Business news daily reported that 39 Indian drug companies have been blacklisted by Vietnam for quality standard violations, along with some others in Bangladesh and South Korea. The Vietnamese regulator has listed the names of all blacklisted companies on its website, without specifying in detail the exact reason behind the bans. The Indian products include, antibiotics and anti-rabies vaccine, among others. The latter was also reportedly banned by the World Health Organization (WHO), in January 2016.

What is more intriguing, despite the Union Ministry of Health and the Ministry of Commerce and Industries of India being aware of it, the issue seems to have drifted beyond reasonable control of the Indian regulators.

Some local companies still not acting:

On Feb 24, 2016, the US and the EU drug regulators reportedly called upon India’s pharmaceutical sector to step up efforts to improve manufacturing standards, and ensure the reliability of data, if it wishes to maintain its dominance in the generic drug industry. In the report, the director of the office of surveillance at the USFDA – Russell Wesdyk was quoted saying, “some Indian companies are still not taking enough steps to identify risks and failures at their firms.”...............

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