Spain: Draf of New Drug Distribution Regulation ignite discussion amongst stakeholders
The Spanish Ministry of Health has unveiled a draft regarding a prospective royal decree which could force pharmaceutical companies to distribute drugs to all wholesaler companies, ending the freedom they already have to decide how they carry out their marketing operations.
In the general meeting of Fedifar, the Spanish wholesalers’ Association, the government unveiled a draft aimed to set out a new regulation of drug distribution. The most controversial point is the obligation for pharma companies to distribute drugs to all wholesaler companies, in a measure attempting to guarantee availability and access to drugs in pharmacies. Fedifar has applauded the draft, but Farmaindustria has raised concerns, including likely legal actions. The draft must be discussed before being sent to Parliament.
To read the full story I have published in www.ihs.com please follow this link.
Chile: Private Hospital Sector Unveils Technical Norm to Increase Transparency of Reimbursement Decisions
The Chilean Association of Private Hospitals has unveiled its plan to set up a technical norm aiming to increase regulation and transparency regarding reimbursement decisions of private health payors, the local La Tercera reported. The guideline has been worked out with the collaboration of private insurers and it will be presented to the authorities, namely the Superintendency of Health, within the next weeks. The aim of the regulation is to clarify doubts that often payors, either private insurance companies or individuals, have in relation to the cost associated with medical services, involving different variables such as severity, surgery room overall costs and difference of cost between services provided during weekdays and weekends.
Indeed Ana Maria Albornoz, representative of the Chilean Association of Private Hospitals which grouped 36 private hospitals in the country, commented that this new regulatory framework will increase transparency throughout the sector, which recently has been questioned by the Chilean Free Competition Advocacy Authority (Fiscalia Nacional Economica, FNE) opening an investigation in order to determine the condition on which private hospitals charge their patients in terms of drugs and medical devices. The announcement made by the FNE came after lawsuits were initiated by patients who were subject to higher charges and what is being described as “abuse of the system”. This situation is caused because providers are not subject to price regulation and nowadays they are part of health networks in connection with private insurance companies, a sort of informal Health Maintenance Organisation. That situation determines that users of the private health system are not able to compare prices and they do not have free choice to decide which provider they want using market mechanisms, because they are caught within the health network of their insurance company.
The new norm, which is almost complete, has received the endorsement of the President of the Private Insurance Companies Association (Isapres), who has agreed that the new norms will increase transparency between providers and payors, because it will establish a clear set of criteria per medical service or procedure and each component will be attached to a certain price. The manoeuvre also has been branded as the creation of a new sort of dialogue between the two sectors.
Despite the modern private health sector that Chile already has, according to this information it seems to be crystal clear that payment mechanisms and other methods of estimating cost within the normal operation of private hospitals were lagging. Even though inconsistencies between providers and payors must have existed, prompting the creation of this new framework, it is clear that private insurance companies have not been affected heavily in terms of revenues and profits, after reports confirmed that profits increased 92% on a year-on-year basis.
However, part of the rationale to explain this manoeuvre could be related to prospective further co-operation between the private and public sector; public hospitals are involved in a similar kind of process driven by the integration of Diagnostic Related Groups (DRGs), a long-awaited reform. If the government has plans to increase even more the partnerships between public and private providers, it is understandable that the requirements are going to be higher, at least in terms of cost transparency. That would help the government to support its movement encouraging the transfer of resources from public to private health.
Brazil Improves Device Assessment for National Health System
This is the report written by Molly Cohen from FDA News about my article regarding the regulatory changes in Device Assessment in Brazil.
A new Brazilian law requires using protocols and guidelines as part of enhanced assessment processes to increase access to medical devices through the country’s national health system, the Sistema Unico de Saude System (SUS).
Law 12.401, proposed by Brazil President Dilma Rousseff, which aims to improve the inclusion of devices in the SUS, will be implemented within the next six months.
It will improve access to high-quality devices that adhere to criteria based on clinical protocols and therapeutic guidelines created by health professionals from different SUS provisions, according to Latin America and Spain analyst for IHS Global Insight Ruben Gennero.
The law allows 180 days for manufacturers to demonstrate compliance with the new effectiveness, safety and cost-effectiveness criteria, with an additional 90 days for extension — an appropriate time to complete the safety and efficacy studies, Gennero said. It also includes a provision for consultation and public input.
Including Devices
The decision to include devices in the SUS will be governed by the National Commission of Technology Incorporation (Comissio Nacional de Incorporacio de Tecnologias, Citec); coordinated by the Ministry of Health and integrated by representatives from the Ministry, the National Agency of Supplementary Health (Agencia Nacional de Saude Suplementar, ANS) and the National Drug Regulator (Agencia Nacional de Vigilancia Sanitaria, Anvisa), as well as one member from the National Health Council and the Federal Council of Medicine, Gennero said.
But even though a reshaping of Citec’s capabilities and the inclusion of new members on the board will ensure transparency, there is also a risk of bureaucracy under the new assessment paradigm, Gennero warns. “The real impact will be measured when the law enters into force within the next six months.”
It introduces periodic assessments of medical technologies offered by the SUS. The assessment criteria cover standards for effectiveness, safety and cost as conditions for the inclusion of new products listed on the SUS, Gennero said.
This is the most recent change in a growing list of changes in Brazil that aim to improve medical device regulation. In April, Brazil’s Attorney-General of the Union restricted Anvisa’s power to examine applications of intellectual property rights on medical products and reduced its role to weighing in on the scope of health risks on the product seeking patenting (IMDRM, April).
Last month, ANVISA began charging inspection fees for certificates of compliance with good manufacturing practice (GMP) and quality control every two years instead of annually to clear up confusion stemming from a 2009 law that called for annual quality system inspection fees while the GMP certification is renewable on a bi-annual basis (IMDRM, May).
Colombia: The crisis affecting the Health System is far from over
The controversial Law 100, set out in 1993, which established the base of the current health system and especially its financial provision, has suffered severe questioning recently, based on the recent intervention in Saludcoop, the biggest health administration company with a portfolio of approximately 4 million Colombians.
Indeed, the Colombian SuperIntendencia de Salud, the state body in charge of overseeing the private insurance sector that is the main reimbursement source of the Colombian Health System, intervened in private insurance company (Entidad Promotora de Salud, EPS) Saludcoop, accused after an investigation of alleged disastrous financial management and being unable to pay providers, debts and more importantly, meet its obligations to patients. In fact, the President of Saludcoop, Carlos Palacino, announced he will step down from the job whilst Superintendencia takes control of the assets and operation of the company, which will continue offering financial protection to its beneficiaries.
The Colombian Minister of Social Protection, Mauricio Santa Maria, has commented in an interview published by the local El Tiempo that actions are required to improve the current situation. Even though political opposition has highlighted the need for a complete change in the system, the current President Santos, coming from the same political ideology of the former President Uribe, is not willing to undergo deep changes. The Minister of Social Protection has said that an enhancement in terms of regulation and price control of certain drugs is important, in order to improve the financial status of EPSs and at the same time, reduce the huge rate of judicial intervention that the system is experiencing. The Minister pointed out that even though Law 100 has increased the access and fairness of the Health System in Colombia, there are some important actions that must be taken in order to increase the transparency and accountability of the system. He ruled out a complete change in the rules and criticised the opposition leaders for trying to take political advantage of this situation. The authority has described one of the big actions will be expansion and improvement of the role of SuperIntendencia de Salud, conducting the overseeing and accountability of the system. The public entity will have an increase in its budget (from 40 billion Colombian pesos/USD22 million to COP80 billion), more inspectors and better technical skills. In addition, he pointed out its aims will be concentrated into three main aspects: quality, flow of resources and opportunity of medical attention. In terms of drug pricing, it is worth noting that in 2006 there was enacted the freedom of pricing. What has been complicating things in the Colombian health system, according to the authorities, is the situation when EPS re-charge the Fosyga (national health fund) for drugs which have been indicated after a litigation process, between patients and EPS. Every time that this situation happens, EPSs allegedly are charging the government more than the normal value of the drugs and in some instances carrying out fraudulent activities, such as charging for drugs for patients who are deceased.
Another big concern of the authorities is when EPSs charge the government for drugs or procedures which are not included in the Compulsory Health Plan, but have been indicated after a litigation process. The Minister has commented that the government is planning to control prices, setting out maximum prices by active pharmaceutical ingredient in the case of the so called re-charge process of EPSs.
Conclusions: The Colombian health system is facing one of its biggest crises after the intervention of Saludcoop. Even though the trigger which ignited the intervention by the Superintendencia de Salud is related to lack of accountability in terms of financial management and insolvency, it has been the opportunity to highlight all the problems that the liberal and privatised Colombian system is experiencing. In fact, the huge presence of justice and litigation as part of the system, given the fact that every time there is a inconsistency between the beneficiary and the EPS, the court ends up intervening, has sent the system into an spiral of overspending. The lack of regulation, overruled by the EPS, and the freedom that they have in terms of deciding where they want to conduct their business, has seen many of these companies investing in golf camps, housing sector and hedge funds abroad, diverting the attention of their core business and some of them failing in their financial obligations. The government is trying to send a message of tranquillity to the markets, however, it is likely that new EPSs are going to be regulated, which could increase the current levels of uncertainty.
Chile: Legislation to Authorise Sale of OTC Drugs Out of Chilean Pharmacies Will Be Difficult
An initiative proposed by the Chilean government aiming to increase access to drugs through expanding the sale of over-the-counter drugs (OTC) to supermarkets and kiosks, as well as other non-pharmacy centres, expects a difficult process within the Chilean parliament, the local newspaper La Tercera informed. Even though the law has been passed by the Economic Commission of the Chamber of Deputies, it will face much tougher resistance in parliament during the discussion. Currently, the Sanitary Code of Chile, which contains the main regulatory aspects of the health sector, explicitly prohibits the sale of drugs outside of pharmacies.
The proposal is being supported by the Ministry of Economy, which commented that through expanding the market for OTC drugs it will be possible to increase access to drugs, especially in places where there is no real distribution of pharmacies; it will also reduce prices due to the entry of new competitors on the market. It is worth noting that, since 1980, there has been no price regulation whatsoever in Chile, which means pricing is entirely dependant on market forces. According to the Ministry of Economy, the introduction of a piece of legislation like this will have the probable outcome of a 20% reduction in OTC drug prices.
The proposed legislation, however, has the opposition of the Pharmaceutical Association of Chile, and it is likely that the Chilean Medical College will meet the group. Moreover, members of parliament (MPs) have stated their concerns about this initiative, focused on the probable increase in the number of cases of drug overdoses and intoxications, along with the unknown impact that such a measure could have on the price of drugs that require a medical prescription. Legislators have pointed out that they will consider the opinions of the stakeholders, among which there is a fierce opposition to the idea.
Even though legislators have raised the concern of the probable increase in overdose cases, the deepest opposition comes from the drug retailers group. Indeed, they have said that there is no benefit in this policy whatsoever, because OTC drugs in Chile currently have the cheapest price in the region. On the contrary, they have said it will create a problem throughout the pharmaceutical market, threatening access to chronic drugs, which represent 10% of the market share. In parallel, pharmacists stand against the proposal because they believe the dispensing of drugs must be supervised by them in order to give proper advice to patients and consumers. According to statistics presented by the organisation, 60% of all intoxications in Chile occur due to misuse of drugs.
In terms of outlook, the legislation seems positive for patients and for the system. Currently, despite the huge presence of pharmacies across
the country, there are still places where it is impossible to find one, namely in the most vulnerable and rural zones. The legislation aims to solve this problem, increasing access to drugs. In terms of prices, statistics provided by the Ministry of Health highlight that prices have gone up 16% over the inflation rate in the last 11 years. Vulnerable groups of the Chilean population spent more than 36% on OTC drugs; the savings provided by this policy would therefore be really important.
The fierce opposition from pharmacies is quite logical. Given the deregulation that the Chilean pharmaceutical sector faces, there is no price control over drugs. This situation has benefited retailers over the last 20 years, resulting in their huge concentration on the market, where three retailer chains currently have 96% of the market share. For them, the expansion in the sale of OTC drugs threatens their dominant position that basically enables them to control prices. The potential law will continue to be discussed in the Health Commission of the Chamber of Deputies, where MPs have commented that its approval will be more complicated than that obtained in the Economic Commission.
Chile: May 21st and Announcements related with Pharmaceutical Market
The President of Chile, Sebastian Piñera, has delivered his National Address of 21 May, which every year brings the national account of the head of state and in addition unveils proposals made by the government for the next fiscal year. In this regards, the president has made several announcements related to the health sector and specifically drug regulation and provision, such as a boost for generic drugs, dispensing of single doses in pharmacies, sales of over-the-counter drugs out of pharmacies and the creation of the new drug regulator agency, ANAMED (See more Creation of New Chilean National Drug Agency to Be Discussed in Parliament-IHS Global Insight Analysis)
The measures proposed by the government of Chile during the national account are a mix of new proposals and initiatives that were made public days before. In fact, the so-called Health Agenda was delivered by the Minister of Health the week before the Presidential Discourse, disclosing a new reform within the pharmaceutical sector in the country. The main proposals are the obligation for doctors to prescribe drugs attaching the active pharmaceutical ingredient name, and in the other hand, a project proposing that pharmacies will be entitled to sell drugs in single-dose format. In addition, the new pharmaceutical law contains initiatives such as the creation of the Chilean drug regulator agency (Agencia Nacional de Medicamentos, Anamed), which was presented to parliament early this month and the controversial project aimed to improve the access of drugs through allowing the sale of over-the-counter drugs out of pharmacies, a piece of legislation heavily resisted by drug retailer chains.
Generics Prescription
The president has stated every prescription in the country must be filled using the brand name of the drug and in addition, the molecule’s name, in order to boost the penetration rate of generics in Chile. The measure come along with the presence of Anamed, the drug regulator agency, which will be in charge of ensuring bioequivalence requirements for such drugs, currently a weak point within the Chilean pharmaceutical sector. The proposal is quite ambitious and at the same time ambiguous. Currently in the public primary care sector, drugs are prescribed using the API’s name so there will be no change in this sector. In regards to the private sector, especially primary care, which is quite used by public insurance holders given the freedom of choice, this measure could have a positive effect. However, in Chile the reimbursement scheme is quite weak, except for Plan Auge, therefore it is still unclear how under such a deregulated environment the government can force doctors on a private basis to prescribe drugs using generic names.
Single-Dose Sales
In parallel, the president has announced that pharmacies will be entitled to sell drugs using a single-dose scheme. In order to achieve that, the president has pointed out the role of pharmacists in the country will be upgraded, and they will be able to dispense the exact amount of drugs for a defined treatment by doctors. The measure has been regarded with scepticism and concerns among the industry and experts, given the fact that it does not take into consideration variables such as quality, safety and traceability of drugs. In fact, without a proper design and changes in the production chain of pharmaceutical companies, it is highly unlikely a measure like this can be useful. On the contrary, it is more likely this measure will threaten the safety of drugs within the country.
Outlook and Implications
The proposal made by the government regarding drug regulation and provision are a list of measures rather than a proper plan aiming to either reduce the pharmaceutical bill or increase access to drugs. In addition, the measure described will not end the big problems that face the Chilean population in terms of access to drugs, given the high deregulation that predominates in the sector and the weak presence of the state in terms of reimbursement. The measures unveiled by the government are just the announcement that need to be discussed in the Parliament after the government discloses the complete proposal through a white paper, which is not known yet. For that reason, it is highly likely there will not be big changes in the Chilean pharmaceutical sector during this period, as the measures tend to be “cosmetic” announcements rather than profound changes.
Pharma emerging markets: what is Latin America’s place within R & D?
This is part of the join post published in PharmaPhorum and written with Valentina Jaramillo, expert in Clinical Research in Latin America.
In a previous post we examined the opportunities offered by Latin-American markets in the pharmaceutical field. The huge growth experienced during the last decade combined with a modern and smart approach taken by governments, such as Brazil, might turn the region into an important player sooner rather than later. Indeed, Brazil is projected to become the fifth largest global pharmaceutical market by 2015, at the current pace…
Keep reading this post here
Cervical Cancer and Latin America, an story of inequality
Data coming from the project Globocan (2008), drawn up by the International Agency for Research on Cancer (IARC) based on information from each country, confirms the suspects that cervical cancer it is the second-most common type of cancer in women in Latin America, after breast cancer. The information is highlighted in a report published by IPS News, flagging that unlike other regions such as US and Europe, a preventable cancer such as cervical still has a high incidence within the region, creating a favourable context for the introduction of Human Papiloma Virus (HPV) vaccine. According to the information provided by IARC, cervical cancer is the most frequent type of cancer in countries with the poorest populations, such as Bolivia, Guatemala, Honduras, Nicaragua and Peru, but also has a high burden in supposedly well off countries such as Argentina, Brazil, Colombia, Costa Rica, Ecuador, Mexico, Paraguay and Venezuela.
According to PAHO, 40 percent of cancer cases diagnosed in the region could be prevented by regular check-ups and physical exercise, a healthy diet, and avoiding smoking and excessive drinking. However, the main prevention strategy, pap smears, has been incapable of bring down the number of new cases especially in poorer countries, mainly due to the lack of appropriate coverage and extension of health services, especially primary care access. HPV vaccines, such as Gardasil (Merck/US) and Cervarix (GSK/UK) might have a major impact in curving down these trend in case governments or PAHO decided to invest in programme aiming to reduce cervical cancer, as well as the economic burden that they cause to the health systems.
CHILE: Government propose new Drug Regulator Agency
The new drug regulator agency will be in charge of ensuring the quality, efficacy and safet of drugs distributed in the country, amongst other functions. Bioequivalence requirements, as part of the legislation, are the flagship of the new public entity.
Peru: Humala calls Int Pharma Companies “monopolistic” and pledges strengthen local industry
The Peruvian presidential contester, Ollanta Humana, who might win the second run-off in a tight presidential election, has stated he will support local pharmaceutical companies against what he has described as “monopolistic” attitudes from international pharmaceutical companies.
In a visit to the plant of the local Laboratorios Induquimica, he pledge that Peruvians will have access to drugs with good quality and fair prices if he is elected, as part of a populist strategy. In addition, Adifan, the Peruvian Pharmaceutical Association, has endorsed Humana’s statement, after he pointed out that the local industry is “battling fiercely” against the pressure exerted by multinational companies, in a language that recalls his alleged link with Venezuelan president Hugo Chàvez. Apart from this aggressive attitude, he did not reveal further details about possible measures against pharmaceutical companies; however, price caps are one possible alternative.
The remarks, published in the local La Republica, mark a break from the moderate image he has been creating since the results of the first round brought him and the far-right candidate Keiko Fujimori to an uncertain second and final election round. His comments have spread concern among markets, including the pharmaceutical sector, regarding the nationalist approach that Humana could take if he wins the election by 5 June. The latest poll published in the Peruvian media shows that both candidates are neck and neck ahead of the second-round run-off election, sowing doubts about the future of one of Latin America’s strongest economic performers, and a key player in the common front that Pacific countries, such as Chile, Colombia and Mexico, want to offer to Asia-Pacific economies.
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