ECONSALUT: Resultats de la cerca de patents

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23 d’abril 2013

Against patents

The case against patents

Some months ago, a WP blog hightlighted a paper by Boldrin and Levine with a straightforward title. Now you can read it at the Journal of Economic Perspectives. The summary is in the first paragraph:

The case against patents can be summarized briefly: there is no empirical evidence that they serve to increase innovation and productivity, unless productivity is identified with the number of patents awarded—which, as evidence shows, has no correlation with measured productivity. This disconnect is at the root of what is called the “patent puzzle”: in spite of the enormous increase in the number of patents and in the strength of their legal protection, the US economy has seen neither a dramatic acceleration in the rate of technological progress nor a major increase in the levels of research and development expenditure.

A risky statement unless there is a clear support from research. However, once you continue reading you'll have arguments to be convinced about it. The impact on pharmaceutical industry is analysed in detail:

There are four things that should be born in mind in thinking about the role of patents in the pharmaceutical industry. First, patents are just one piece of a set of complicated regulations that include requirements for clinical testing and disclosure, along with grants of market exclusivity that function alongside patents. Second, it is widely believed that in the absence of legal protections, generics would hit the market side by side with the originals. This assumption is presumably based on the observation that when patents expire, generics enter immediately. However, this overlooks the fact that the generic manufacturers have had more than a decade to reverse-engineer the product, study the market, and set up production lines. Lanjouw’s (1998) study of India prior to the recent introduction of pharmaceutical patents there indicates that it takes closer to four years to bring a product to market after the original is introduced—in other words, the fifi rst-mover advantage in pharmaceuticals is larger than is ordinarily imagined. Third, much development of pharmaceutical products is done outside the private sector; in Boldrin and Levine (2008b), we provide some details. Finally, the current system is not working well: as Grootendorst, Hollis, Levine, Pogge, and Edwards (2011) point out, the most notable current feature of pharmaceutical innovation is the huge “drought” in the development of new products.

And the proposal is a controversial one:

we could either treat Stage II and III clinical trials as public goods (where the task would be financed by National Institutes of Health, who would accept bids from firms to carry out this work) or by allowing the commercialization of new drugs—at regulated prices equal to the economic costs of drugs—if they satisfy the Food and Drug Administration requirements for safety even if they do not yet satisfy the current (overly demanding) requisites for proving efficacy.

The last sentence sounds far from what should be a "fair" regulatory process in pharmaceuticals. Anyway, it seems that we have entered in a new perspective on patents and more scholars will be supporting it in the future. I'm close to this perspective, but the details are important, as usual.

02 de juny 2023

Patentant tranquil·lament els gens com aquell que no fa res

International Divergence in Gene Patenting

Si hi ha un disbarat regulatori descomunal global, aquest és el de les patents genètiques. En aquest blog he parlat repetidament de la qüestió, i ho podeu trobar aquí (sobre patents genètiques i en general). Fa tretze anys que ja defensava que la natura no es pot patentar, però la realitat és que ja hi ha milers de patents vigents, i el mal ja està fet. I alhora ens trobem davant d'un món globalitzat i en canvi les regulacions són estatals. El resultat és que les patents atorguen monopolis altament rendibles i hi ha una divergència en com es consideren les patents genètiques arreu, i en aquest article hi ha el resum:

In the United States, isolated naturally occurring nucleotide sequences are not eligible, and methods of using them are not eligible if they are conventional and routine. By contrast,cDNA sequences remain eligible.
In Australia, isolated naturally occurring nucleotide sequences and equivalent cDNA sequences are not eligible, but methods of using them remain eligible.
In Canada, these issues remain undecided legally, although the willingness of patentees to compromise could be seen as an indication that they saw the validity of their patents as tenuous.
In Europe, isolated naturally occurring nucleotide sequences, equivalent cDNA sequences,and methods of using them remain eligible.
In China, the eligibility of isolated and cDNA sequences remains undecided, though diagnostic methods may not be eligible.

Cal llegir l'article per entendre la complexitat. Ara bé, no veig cap interès per afrontar aquesta qüestió des del seu principi. Els lobbys treballen a tot ritme per salvaguardar els monopolis, l'Organització Mundial de Comerç passa olímpicament de les patents una vegada ja s'estan aplicant, la WIPO protegeix el negoci, i els reguladors estan de vacances. L'impacte que té això és immens. Aquesta és la situació a data d'avui.

PS. Una sequència de nucleòtids es pot patentar a data d'avui i alguns diuen que això no és natura sinó manipulació humana (cDNA), i jo em pregunto hi hauria manipulació sense natura? Doncs aquesta és la qüestió clau. Cal barrar el pas a les patents genètiques. Les patents redueixen la innovació i creen incertesa a un gran cost per la societat, ho vaig explicar aquí.

12 de març 2014

Against patents, again

Deadly Monopolies: The Shocking Corporate Takeover Of Life Itself – And The Consequences For Your Health And Our Medical Future

I've just finished reading a book on patents in life sciences. As you know from previous posts , I'm convinced that there is an enormous welfare loss from current patent system. If you have the opportunity to read this book, you'll finally will arrive at the same conclusion. Although it was written before the Supreme Court ruling over the Myriad case, the message is still the same: patents contrain innovation and are extremely costly to the society. The case of Hepatitis C is explained in detail. Until some patents were exhausted there was no possibility to start research. Without such patents, new succesful and (costly) treatments have arisen (and afterwards have been patented again).
An interesting interview in Forbes magazine highlights the key issues of the book. Unfortunately times go by and alternatives to patents are not taking off.

30 d’octubre 2010

Cop de timó

U.S. Says Genes Should Not Be Eligible for Patents

Finalment sembla que les patents sobre el gens no seran admisibles als Estats Units. Aquest fet és molt important perquè durant anys s'han acceptat patents sobre seqüencies genòmiques i això ha donat lloc a gran controvèrsia. Sorprèn que a Catalunya no hagi preocupat la qüestió. Vaig escriure un article on mostrava la situació fruit d'un litigi al mes de març passat. Ara després de l'apel.lació tot sembla que torna al seu lloc natural.
Aquest paràgraf de NYT mostra les posicions:

The issue of gene patents has long been a controversial and emotional one. Opponents say that genes are products of nature, not inventions, and should be the common heritage of mankind. They say that locking up basic genetic information in patents actually impedes medical progress. Proponents say genes isolated from the body are chemicals that are different from those found in the body and therefore are eligible for patents.

El sentit comú s'imposa, el que no sé és com es rebrà tot plegat a la legislació europea que s'ha mostrat dubitativa en molts aspectes. Convé estar alerta doncs. Avui hem de mosrar-nos satisfets pel que ha succeït fruit de molts anys de lluita als tribunals nord-americans.

07 de maig 2021

Patents are Not the Problem (right now)!

I agree absolutely with Alex Tabarrock and his post in Marginal revolution. He says:

Patents are not the problem. All of the vaccine manufacturers are trying to increase supply as quickly as possible. Billions of doses are being produced–more than ever before in the history of the world. Licenses are widely available. AstraZeneca have licensed their vaccine for production with manufactures around the world, including in India, Brazil, Mexico, Argentina, China and South Africa. J&J’s vaccine has been licensed for production by multiple firms in the United States as well as with firms in Spain, South Africa and France. Sputnik has been licensed for production by firms in India, China, South Korea, Brazil and pending EMA approval with firms in Germany and France. Sinopharm has been licensed in the UAE, Egypt and Bangladesh. Novavax has licensed its vaccine for production in South Korea, India, and Japan and it is desperate to find other licensees but technology transfer isn’t easy and there are limited supplies of raw materials:
Virtually overnight, [Novavax] set up a network of outside manufacturers more ambitious than one outside executive said he’s ever seen, but they struggled at times to transfer their technology there amid pandemic travel restrictions. They were kicked out of one factory by the same government that’s bankrolled their effort. Competing with larger competitors, they’ve found themselves short on raw materials as diverse as Chilean tree bark and bioreactor bags. They signed a deal with India’s Serum Institute to produce many of their COVAX doses but now face the realistic chance that even when Serum gets to full capacity — and they are behind — India’s government, dealing with the world’s worst active outbreak, won’t let the shots leave the country.
Plastic bags are a bigger bottleneck than patents. The US embargo on vaccine supplies to India was precisely that the Biden administration used the DPA to prioritize things like bioreactor bags and filters to US suppliers and that meant that India’s Serum Institute was having trouble getting its production lines ready for Novavax. CureVac, another potential mRNA vaccine, is also finding it difficult to find supplies due to US restrictions (which means supplies are short everywhere). As Derek Lowe said:
Abolishing patents will not provide more shaker bags or more Chilean tree bark, nor provide more of the key filtration materials needed for production. These processes have a lot of potential choke points and rate-limiting steps in them, and there is no wand that will wave that complexity away.
Technology transfer has been difficult for AstraZeneca–which is one reason they have had production difficulties–and their vaccine uses relatively well understood technology. The mRNA technology is new and has never before been used to produce at scale. Pfizer and Moderna had to build factories and distribution systems from scratch. There are no mRNA factories idling on the sidelines. If there were, Moderna or Pfizer would be happy to license since they are producing in their own factories 24 hours a day, seven days a week (monopolies restrict supply, remember?). Why do you think China hasn’t yet produced an mRNA vaccine? Hint: it isn’t fear about violating IP. Moreover, even Moderna and Pfizer don’t yet fully understand their production technology, they are learning by doing every single day. Moderna has said that they won’t enforce their patents during the pandemic but no one has stepped up to produce because no one else can.

28 de març 2012

Quan les patents bloquegen la innovació

Biomedical Patents

Ja fa temps em vaig referir al cas de Prometheus, un laboratori que ofereix una prova diagnòstica que permet determinar la dosi acurada d'un medicament:

A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder comprising two steps: (a) administering one of a class of drugs (thiopurines) and (b) determining the level of a specified metabolite, "wherein" a level below a given threshold "indicates a need to increase the amount of said drug subsequently administered" [to improve efficacy], and a level above the threshold "indicates a need to decrease the amount of said drug subsequently administered" [to avoid toxicity].

Aleshores vaig dir que s'havia obert la caixa dels trons perquè havien guanyat el cas, doncs bé ha anat a parar al Tribunal Suprem i l'han perdut. Aquesta és una bona notícia per als ciutadans, i menys bona per Nestlé que n'és el propietari. És rellevant perquè aleshores ja vaig dir que patentar les lleis de la natura representaria una barrera a l'accés a d'altres innovacions. Els de Genomic law report ho resumeixen així:

The laws of nature involved here are the "relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm." The legal question then becomes, "do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws?" For all nine members of the Court, the answer was a clear no.

I per a mi encara és més rellevant tenir en compte que han acabat al Suprem perquè han estat els metges qui han encetat novament el procés. L'American Medical Association i altres grups de metges s'han plantat contra el laboratori i les empreses de biotecnologia. Em costa d'imaginar una cosa semblant per aquí aprop, tot i que em sembla absolutament acurat. El seu argument és que patentar lleis de la natura privarà la recerca en el futur i els han donat la raó. Altrament les patents que suposadament serveixen per promoure la innovació provocarien l'efecte contrari, fet que ja passa en determinades ocasions.
Veurem si després d'això, Europa reacciona. Per ara el que ens cal és un millor comprensió de la situació i reaccionar assenyadament. A UK han editat un opuscle per als diputats que convindria que tots els d'aquí el llegissin quan més aviat millor.

PS. A NEG sobre el tema de patents.

23 de febrer 2017

Genome editing, closer than you think

Human Genome Editing Science, Ethics, and Governance

Last week the US patent office ruled that hotly disputed patents on the CRISPR revolutionary genome-editing technology belong to the Broad Institute of Harvard and MIT. In a former post I explained the dispute. Genome editing in my opinion shouldn't be patented and will see exactly the impact of such ruling in US and elsewhere in the next future.
If you want to know in detail what does genome editing means for the future of life sciences, have a look at NASEM book.

It is now possible to insert or delete single nucleotides,interrupt a gene or genetic element, make a single-stranded break in DNA, modify a nucleotide, or make epigenetic changes to gene expression. In the realm of biomedicine, genome editing could be used for three broad purposes: for basic research, for somatic interventions, and for germline interventions.

CRISPR (which stands for clustered regularly interspaced short palindromic repeats) refers to short, repeated segments of DNA originally discovered in bacteria. These segments provided the foundation for the development of a system that combines short RNA sequences paired with Cas9 (CRISPR associated protein 9, an RNA-directed nuclease), or with similar nucleases, and can readily be programmed to edit specific segments of DNA. The CRISPR/Cas9 genome-editing system offers several advantages over previous strategies for making changes to the genome and has been at the center of much discussion concerning how genome editing could be applied to promote human health.

I would just want to say that these patents destroy the soul of science, since access should be available with no barriers for the development of innovation. Patents are not the incentive for discovery in this case, as I explained in my post, natural processes should'nt be patented. And this is why today is a really sad day.

PS. My posts against patents

Michael Kiwanuka. Home again

24 de març 2022

Free our genes

The Genome Defense Inside the Epic Legal Battle to Determine Who Owns Your DNA

30 de maig 2012

Una galleda d'aigua freda

Tots aquells que esperaven patentar biomarcadors relacionats amb la dosificació de medicaments s'han quedat de pedra al saber el resultat del tribunal suprem dels USA. En una decisió unànime ha dit que els mètodes per a determinar la dosi terapèutica d'un medicament no poden ser patentats. Les lleis de la natura resten al marge de les patents, les simples correlacions no són suficients. Des de Nature diuen que això farà molt difícil patentar mètodes diagnòstics predictius que depenen de la presència o absència d'un marcador. I d'aquesta manera han situat a tota una indústria en un altre model de negoci que no esperaven, el de l'open-source.
I al NEJM diuen:

With this decision, the Supreme Court has taken a bold step, proscribing patents from covering correlations used in making biomarker- based diagnoses when those patents simply describe “steps that must be taken in order to apply” the natural law in question. In addition, bundling the diagnosis with the step of administering
a man-made drug does not make a biomarker discovery a patentable invention. A patentable process now needs to involve an inventive and novel application of a law of nature beyond “wellunderstood, routine, conventional activity, previously engaged in by those in the field.”

Encara desconec quina serà la reacció europea. Segur que serà tard i malament, tal com ens tenen acostumats. Alguns laboratoris ja han previst això i han decidit que cal enviar-los les mostres i per tant no comercialitzaran el test i la caixa negra será més negra encara.
Per aquí aprop seria una grata sorpresa que el regulador encarés aquest tema amb rapidesa i desapareguessin les incerteses. Ho dubto, però tant de bo.

Dijous passat a la Sala Apolo vam tenir ocasió de veure'l en directe,

aquí us deixo a l'Eli Paperboy Reed, carregat d'energia i bones vibracions

20 d’octubre 2015

The Theranos contretemps as a serious scandal

Last Thursday WSJ released a long article on Theranos clinical lab. In this blog you may check my February and July posts on this firm under the title: A closely guarded secret. As you may imagine, such a title was not coincidental. There were some clues that justified it, something unusual was happening. And WSJ has contributed to shed light on the issue. All the details in it. Basically, the summary is that analytic validity and clinical validity is under compromise. This is an exemple:

If you want to read a first person account, you'll find it here and here. Some additional articles: Wired, New Yorker, Clinical Chemistry and Laboratory Medicine (CCLM), Forbes, NYT, WP,...
This is not only a contretemps, it is a serious scandal and a huge problem to credibility for this start-up.
From Wired:

Theranos got a lot of traction by tapping into the frustration—both from consumers and the medical community—that diagnostic testing is too painful, too slow, and too expensive. “Their problem is they tried to do it with existing diagnostic instrumentation, instead of innovating new diagnostic instrumentation,”

Theranos is a black box that has touted results rather than process. “The ability of the lab medicine community to police and correct itself depends on that flow of information,” says Master. Instead, Theranos’ research was internal, and rather than submit their work to peer review the company cited their FDA approvals as evidence that the technology worked.

At least in the USA there is a regulator, the FDA, lab regulation in Europe was enacted in 1998, completely outdated under a third party scheme, not a direct public regulator. Therefore, there is a pressing motive to speed up new and different rules in Europe. Microfluidics and nanotechnologies are calling for and urgent overhaul.

PS. An statement from WSJ:

In 2005, Ms. Holmes hired Ian Gibbons, a British biochemist who had researched systems to handle and process tiny quantities of fluids. His collaboration with other Theranos scientists produced 23 patents, according to records filed with the U.S. Patent and Trademark Office. Ms. Holmes is listed as a co-inventor on 19 of the patents.

The patents show how Ms. Holmes’s original idea morphed into the company’s business model. But progress was slow. Dr. Gibbons “told me nothing was working,” says his widow, Rochelle. In May 2013, Dr. Gibbons committed suicide. Theranos’s Ms. King says the scientist “was frequently absent from work in the last years of his life, due to health and other problems.” Theranos disputes the claim that its technology was failing.

27 de maig 2024

Els motius i les conseqüències de l'elevat preu dels medicaments

Prescription for the People

El contingut del llibre (orientat als USA):

Introduction

Part I

1. People Everywhere Are Struggling to Get the Medicines They Need

2. The United States Has a Drug Problem

3. Millions of People Are Dying Needlessly

4. Cancer Patients Face Particularly Deadly Barriers to Medicines

5. The Current Medicine System Neglects Many Major Diseases

Part II

6. Corporate Research and Development Investments Are Exaggerated

7. The Current System Wastes Billions on Drug Marketing

8. The Current System Compromises Physician Integrity and Leads to Unethical Corporate Behavior

9. Medicines Are Priced at Whatever the Market Will Bear

10. Pharmaceutical Corporations Reap History-Making Pro ts

Part III

11. The For-Profit Medicine Arguments Are Patently False

12. Medicine Patents Are Extended Too Far and Too Wide

13. Patent Protectionism Stunts the Development of New Medicines

14. Governments, Not Private Corporations, Drive Medicine Innovation

15. Taxpayers and Patients Pay Twice for Patented Medicines

Part IV

16. Medicines Are a Public Good

17. Medicine Patents Are Arti cial, Recent, and Government-Created

18. The United States and Big Pharma Play the Bully in Extending Patents

19. Pharma-Pushed Trade Agreements Steal the Power of Democratically Elected Governments

Part V

20. Current Law Provides Opportunities for Affordable Generic Medicines

21. There Is a Better Way to Develop Medicines

22. Human Rights Law Demands Access to Essential Medicines

Conclusion

Notes

Index

01 de març 2023

La gallina dels ous d'or existeix. Com generar 200.000.000.000$ de facturació?

Estem parlant d'un anticos monoclonal, l'adalimumab (Humira), antiinflamatori per artritis. Un laboratori nordamericà va comprar un altre laboratori alemany per 6.900 milions de dòlars fa 23 anys. Actualment el cost per pacient i any és als USA, 80.000$. Ara ja han assolit en total uns ingressos procedents d'aquest medicament per import 200 mil milions de dòlars, gairebé 30 vegades la inversió. L'origen cal buscar-lo a la Universitat de Cambridge, on l'investigador va guanyar el premi Nobel.

I aquí tornem a enfrontar-nos amb el sistema de patents. Encara que van caducar el 2016 han aconseguit anar-la extenent fins l'actualitat, i això es fa creant barreres legals als competidors de biosimilars.

Sabem que l'empresa no va investigar, sinó que va comprar l'investigació en fase avançada a una altre empresa. És a dir, va comprar un actiu financer que tenia una protecció de monopoli. Sabem que la investigació es va fer en una Universitat i que encara no ens han explicat com es va finançar però tots podem intuir-ho. Sabem que fa més de 20 anys! I les patents encara són vigents?

Algú s'ho pot mirar i fer alguna cosa? Té sentit tot plegat? La pregunta d'en John Gapper és encertada: Do big companies that acquire the likely winners merit more than 20 years of patent protection?

La gallina dels ous d'or existeix perquè els humans hem dissenyat la regulació que permet la seva existència. El sistema de patents i el sistema de preus estaven pensats per un altre context. Ara algú ha aconseguit el calibratge fi del sistema i per això som on som. Això és només un avís del que vindrà properament.

Avui en Harry Belafonte fa 95 anys i els de Gramophone van fer aquesta magnífica versió

17 de novembre 2023

Els nirvis de la indústria farmacèutica europea

Assessment of main provisions and key EFPIA recommendations on the revision of the pharmaceutical package

La proposta de nova regulació farmacèutica europea ha desfermat la preocupació a una indústria que ja havia d'estar preocupada abans que això passés. I és que només veient els medicaments que s'han aprovat els darrers temps i la inversió en recerca recent, sabem que anem a empentes i rodolons.

En aquest context hi ha nirvis de la indústria sobretot per dues coses: per la protecció de dades regulatòries i per l'exclusivitat de mercat dels medicaments orfes. Diguem-ho clar, perquè la regulació de patents segueixi protegint d'igual forma el monopoli temporal. Aquest és el concepte. Després ve el detall de facilitar l'accés als medicaments per part dels pacients, però això ja són els serrells.

Ahir UK ja va aprovar el Exa-cel, el medicament de CRISPR Therapeutics i ho va fer amb dues indicacions, anèmia de cèl·lules falciformes i beta-thalassemia. És la primera vegada al món que s'aprova definitivament una teràpia genètica ex-vivo basada en CRISPR. A la FDA un consell assessor va donar la seva aprovació que s'espera sigui definitiva el dia 8 de desembre.

Curiosament CRISPR Therapeutics té la seu social a Europa ,no-UE , a Suïssa, a Zug. La va fundar Emmanuelle Charpentier fa 10 anys, guanyadora del Nobel amb Jennifer Doudna. Ara bé, només hi té la seu social. Tot, tot s'ha fet junt amb Vertex a Boston. Si mirem la vacuna de Pfizer va ser originada a Alemanya (Biontech), però va comercialitzar-se com nord-americana. Podríem repassar molts més exemples on la recerca europea és potent i la comercialització s'esvaeix. Però això no ho arreglarà la protecció mitjançant patents.

La indústria europea ens explica en un document quina serà la seva estratègia de lobby per als propers mesos i després d'explicar que la redacció actual provocarà el diluvi universal (menys accés als medicaments), diu el que cal fer (RDP vol dir protecció de dades regulatòries i OME vol dir exclusivitat de mercat de medicaments orfes):

In line with the European Council Conclusions (March 2023), Europe needs to strengthen, rather than cut, the region’s RDP baseline and OME.
Providing meaningful and predictable incentives, attainable fairly, that would encourage additional R&D investment compared to today.
Jointly addressing barriers and delays to access based on a shared understanding of the evidence generated by the European Access Hurdles Portal.
Limiting Bolar exemption for activities related to seeking regulatory approval.
Developing a patient-centred, more inclusive definition of unmet medical need.
By acknowledging the value of innovation and encouraging advancements in prevention, treatments and care, Europe can ensure that no patient is left behind.
A robust framework for mechanism of action Paediatric Investigation Plans (PIPs) is essential to ensure that this new obligation is effective to achieve its purpose and is manageable for developers.
Further optimising the regulatory framework and ensuring maximum use of expedited pathways in support of patient needs.
Ensuring that supply chain and environmental requirements are proportionate and fit-for-purpose while not prohibiting or delaying patient access to medicinal products.

No entrarem en detall de cada qüestió ara. Convé repassar el document. Únicament caldria dir que anem molt endarrerits en el temps amb la regulació farmacèutica a Europa i això ens ha fet perdre pistonada. Que hi ha retards en l'accés, ho sabem, però aquest és sobretot un problema dels països i dels seus recursos financers. Convindria que la reflexió no fos tant en la protecció de patents i en canvi en els incentius a la recerca necessària per a millorar la salut poblacional. Per tant una reflexió conjunta, indústria i governs, de quines haurien de ser les prioritats i establir mecanismes per a dur-ho a terme (d'això no n'he vist res a la regulació proposada). Posar incentius sense assenyalar prioritats no ens menarà a una solució dels problemes actuals. Ho sabem també.

Albarrán Cabrera

06 de novembre 2013

Courts as market makers

Recent decision invalidating Myriad patents has had immediate results. The market of genetic tests on breast and ovarian cancer has new entrants. The price of the test has decreased 40% (!) in just four months after the resolution. More entrants are expected in the next future for more tests.
The question is still the same, is there any clear cost-effectiveness analysis available for such tests? Why homebrew tests (LDT) are beyond any regulation? Does any regulator care about all this issues?. The answer is: up to now, we can't see any efforts. Patents create artificial monopolies, courts may create markets when invalidate patents, but patients are concerned about health improvement and value. In an asymetric information environment, the regulator can't take permanent holidays. Overdiagnosed population doesn't necessarily mean healthier population.

Forbes Healthcare Summit 2013

Insurance Companies Enter A New World

14 de desembre 2022

Making competition work

Antitrust Policy in Health Care Markets

After reviewing all these issues included in the book, do you still think that true competition could work in health care?

In US, the evidence is that remedies doesn't cure the disease (collusion, monopoly, dominant position abuse).

Contents:

1. Health Care Markets and Competition Policy 1

1.1 The Marketplace of Health Care Spending 1

1.2 Competitive Concerns 3

1.3 Antitrust Policy 4

1.4 Plan of the Book 5

1.5 Concluding Remarks 12

2 Antitrust Policy in the United States 14

2.1 Introduction 14

2.2 The Economic Rationale for Antitrust Policy 14

2.3 Political Foundation of Antitrust Policy 19

2.4 Antitrust Treatment of Monopoly and Cartels 23

2.5 The Clayton Act 26

2.6 Private Antitrust Suits 27

2.7 Class Action Suits 31

2.8 Concluding Remarks 33

PART I MONOPOLY 35

3 Patents and Monopoly Pricing of Pharmaceuticals 37

3.1 Introduction 37

3.2 The Patent System 39

3.3 Patents and Monopoly Pricing 42

3.4 Patent Licensing 47

3.5 Antitrust Remedies 51

3.6 Government Policy Proposals toward Prescription

Drug Pricing 52

3.7 Extensions: Medical Devices and Orphan Drugs 64

3.8 Concluding Remarks 68

4 Patents and Exclusionary Product Hopping 74

4.1 Introduction 74

4.2 Exclusionary Product Hopping 75

4.3 Legal Challenges to Product Hopping 78

4.4 Solutions, If Any 88

4.5 Concluding Remarks 92

5 Bundled Discounts and PeaceHealth 95

5.1 Introduction 95

5.2 Bundled Discounts 96

5.3 Bundled Discounts in Health Care Settings 99

5.4 Anomalies of the Discount Attribution Test 105

5.5 Antitrust Treatment of Bundled Discounts 109

5.6 Concluding Remarks 112

PART II SELLER CARTELS 113

6 Collusion in Health Care Markets 117

6.1 Introduction 117

6.2 A Basic Cartel Model 117

6.3 Collusion among Physicians and Surgeons 121

6.4 Collusion among Hospitals 126

6.5 Collusion among Pharmaceutical Manufacturers 128

6.6 Collusion among Medical Device Manufacturers 131

6.7 Collusion among Health Insurers 132

6.8 Concluding Remarks 134

7 Collusion in Generic Drug Markets 136

7.1 Introduction 136

7.2 The Competitive Promise of Generic Pharmaceuticals 137

7.3 The Incentive to Collude 140

7.4 The Alleged Conspiracies 142

7.5 Economic Consequences of Collusion 150

7.6 Deterring Price Fixing 152

7.7 Concluding Remarks 154

Appendix: Alleged Participants in Generic Pharmaceutical

Drug Conspiracy 154

8 The Hatch-Waxman Act, Patent Infringement Suits,

and Reverse Payments 168

8.1 Introduction 168

8.2 The Hatch-Waxman Act 169

8.3 Reverse Payment Settlements 172

8.4 The Actavis Decision 177

8.5 The Post-Actavis Experience 186

8.6 Legislative Remedies 192

8.7 Private Damage Actions 197

8.8 Concluding Remarks 200

Appendix: The Economics of Settlements 200

9 The Alleged Insulin Conspiracy 204

9.1 Introduction 204

9.2 Insulin: A Brief History 205

9.3 The US Insulin Market 207

9.4 Pharmacy Benefit Managers 215

9.5 Collusion in the Insulin Market 220

9.6 Concluding Remarks 225

10 Licensing of Health Care Professionals 230

10.1 Introduction 230

10.2 Economic Concerns with Professional Licensing 232

10.3 North Carolina Dental and the State Action Doctrine 236

10.4 Licensing to Exclude Competition 242

10.5 Economic Effects of Mandated Supervision 245

10.6 The Empirical Evidence 249

10.7 Concluding Remarks 250

PART III MONOPSONY 255

11 Monopsony, Dominant Buyers, and Oligopsony 257

11.1 Introduction 257

11.2 Basic Model 258

11.3 Dominant Buyer Model 267

11.4 Oligopsony 270

11.5 Monopsony in Health Insurance Markets 273

11.6 Antitrust Treatment of Monopsony 275

11.7 Concluding Remarks 277

12 Countervailing Power: Physician

Collective Bargaining 279

12.1 Introduction 279

12.2 Bilateral Monopoly 280

12.3 Physician Cooperative Bargaining 286

12.4 Competitive Concerns 296

12.5 Concluding Remarks 298

13 Group Purchasing Organizations, Monopsony, and

Antitrust Policy 300

13.1 Introduction 300

13.2 What Do We Know about GPOs? 301

13.3 GPOs and the Exercise of Monopsony Power 302

13.4 Foreclosure of Suppliers 307

13.5 GPO Funding Mechanisms 312

13.6 Antitrust Enforcement Policy 315

13.7 Concluding Remarks 319

PART IV BUYER CARTELS 323

14 Collusion in the Nurse Labor Market 325

14.1 Introduction 325

14.2 The Shortage of Nurses 326

14.3 A Simple Analysis of an Employer Cartel 329

14.4 Recent Antitrust Litigation 333

14.5 Antitrust Damages 336

14.6 Antitrust Policy 341

14.7 Concluding Remarks 343

15 Collusion in the Oocyte Market 345

15.1 Introduction 345

15.2 Collusion in the Oocyte Market 346

15.3 Antitrust Standards 348

15.4 Economic Effects of Price Ceilings 351

15.5 Rule of Reason Analysis 352

15.6 Antitrust Injury and Damages 357

15.7 Disposition of Kamakahi 362

15.8 Concluding Remarks 365

16 No-Poaching Agreements and Antitrust Policy 368

16.1 Introduction 368

16.2 Background 370

16.3 No-Poaching Agreements in Health Care:

Seaman v. Duke University 373

16.4 Damage Theory 375

16.5 Government Regulation 381

16.6 Concluding Remarks 383

PART V MERGERS AND ACQUISITIONS 385

17 The Economics of Horizontal Mergers 389

17.1 Introduction 389

17.2 Mergers to Monopoly 390

17.3 Mergers of Producers to Realize Efficiencies 393

17.4 Mergers of Buyers to Realize Efficiencies 397

17.5 Merger Efficiencies Resulting in Increased Quality 401

17.6 Concluding Remarks 404

18 Horizontal Merger Policy 405

18.1 Introduction 405

18.2 Horizontal Merger Policy 406

18.3 Defining the Relevant Antitrust Market 410

18.4 Economic Evidence of Competitive Effects 412

18.5 Mergers and Their Anticompetitive Effects: Sutter

Health 415

18.6 Agency Analysis of Mergers in Health Care Markets 419

18.7 Concluding Remarks 431

19 The Economic Theory of Vertical Integration 434

19.1 Introduction 434

19.2 Vertical Integration 435

19.3 Vertical Integration and Competitive Distribution 439

19.4 Successive Monopolies in Production and Distribution 444

19.5 Competitive Concerns with Vertical Mergers 448

19.6 Empirical Evidence on Vertical Mergers 450

19.7 Mergers of Complementary Input Suppliers 451

19.8 Concluding Remarks 455

20 Vertical Merger Policy 457

20.1 Introduction 457

20.2 Legal Foundation 458

20.3 The 2020 Vertical Merger Guidelines 461

20.4 A Merger in Biotechnology: Illumina/GRAIL 465

20.5 The Merger of a Health Insurer and a Physician Group:

UnitedHealthcare/DaVita 469

20.6 The Merger of a Hospital System and a Physician Group:

St. Luke’s/Saltzer 472

20.7 Concluding Remarks 476

21 Concluding Remarks

29 de juliol 2022

Against patents, again (3)

Patent Politics. Life Forms, Markets, and the Public Interest in the United States and Europe

Comparing battles over patents on animals, human embryonic stem cells, human genes, and plants in the United States and Europe, she shows how political culture, ideology, and history shape patent system politics. Clashes over whose voices and which values matter in the patent system, as well as what counts as knowledge and whose expertise is important, look quite different in these two places. And through these debates, the United States and Europe are developing very different approaches to patent and innovation governance. Not just the first comprehensive look at the controversies swirling around biotechnology patents, Patent Politics is also the first in-depth analysis of the political underpinnings and implications of modern patent systems, and provides a timely analysis of how we can reform these systems around the world to maximize the public interest.

20 de gener 2017

Stimulating ideas for drug development and pricing

New Health Technologies. Managing Access, Value and Sustainability

This new OECD report sheds light over several issues in an heterogeneous way, but the pharma chapter has a box that I want to highlight. It is really suggestive:

Future scenarios about drug development and drug pricing

These disruptive scenarios result from an expert consultation led by ShiftN and commissioned by the Belgian Health Care Knowledge Centre of Expertise and the Dutch Health Care Institute. The aim of the consultation was to imagine disruptive ways to finance R&D that could potentially better respond to public health needs.

Scenario 1: Needs-oriented Public-Private Partnerships
Public actors and drug developers are tackling public health priorities in vigorous and pragmatic partnerships. The public actor identifies indications representing high public health needs; specifies criteria for the performance levels of drugs to be developed for those indications; and indicates his willingness to pay. Through procurements with enforceable contractual commitments, the public actor enters into a partnership with drug developers to
find solutions for these needs. Developers are prepared to enter into the partnership and to give price concessions for a pre-negotiated fixed agreement on price and volume, and speedier access to market, which reduces their development risk. This drug development and pricing model is close to existing governmental procurement practices in researchintensive areas such as public transport, defence and space exploration.

Scenario 2: Parallel Drug Development Track
EU member states set up a parallel, not-for-profit drug development track that exists alongside, but independent of, the pharmaceutical and biotechnological industry. The aim of the parallel track is to develop cheaper drugs without compromising safety and effectiveness. After having made up an inventory of the public health gaps and priorities in health care, EU member state authorities ask leading public research institutes which
discoveries, assets, tools and capabilities they possess to develop solutions addressing (some of) the needs that were identified. Starting from the match between demand and available expertise, coalitions are built between these (not-for-profit) research institutes, payers, authorities and patients’ organisations. All these partners make the commitment to participate in an open and transparent way in clinical research projects. Intellectual
property (IP) rights are acquired early on in the development process by the partners of the consortium, and ownership is shared. Alternatively, the parallel research infrastructure can completely deprioritise ownership; i.e. inventions and developments in the parallel track are not protected and are in the public domain.

Scenario 3: Pay for Patents
A consortium of European countries join forces and establish a “Public Fund for Affordable Drugs”. Each of the participating countries deposits a fixed annual percentage of what it currently spends on drugs into the Fund. Private payers (including insurance companies) can also join the Fund. The Fund continuously screens the research market for “interesting” drugs that are being developed in Phase II or in Phase III for indications with clear health priorities. The Fund buys the patent from developers, conducts or commissions the last phases of research in public research institutes or subcontracts to private partners (with strict public oversight), and guides the submission process for market authorisation. Because the drug is then put on the market at a relatively low price, substantial savings are generated for the public payer. Once the system is functioning “at cruising speed”, these
savings can (partly) serve to replenish the Fund. The “Pay for Patents” model delinks R&D from manufacturing and sales. The prices decrease because the partners in the Fund consider medicines as public goods that should not be financed through monopoly prices.
Hence, once the patent is owned by the public sector, after a successful development and authorisation trajectory, the rights to produce, distribute and sell the drug can be licenced to manufacturers and distributors that provide the best deal in terms of quality, safety and accessibility for the lowest cost. As a rule, various private partners compete with each other, with the result that “new drugs enter the market at generic prices”.

Scenario 4: Public Good from A to Z
Drug development is essentially a public enterprise, and is radically re-oriented from serving private profits towards serving the public interest and patients’ needs. In a drug development system that is essentially a public enterprise, private drug companies still have a role, albeit with a completely different business model. They mainly manufacture drugs and deliver services to the public provider on a competitive basis. With drugs and other health technologies essentially public goods, patents and monopolistic prices have no role.
Patients and public health providers, not corporations, choose which unmet needs research should address. Public authorities regularly publish lists of research priorities, based on objectively established and patient-informed unmet medical needs. Governments organise and fund that research through a variety of mechanisms, including requests for proposals based on well-defined targets that any research team, public or private, can compete for, or milestone compensation, and active management of the innovation process. By paying directly for R&D and active management of the drug development pipeline, nations and health care systems pay much less than the patent-protected prices of the past. Ultimately, drug prices are set on the basis of the real costs of manufacturing, quality control and distribution, which are decoupled from R&D.
Source: Vandenbroeck, Ph. et al. (2016), “Future Scenarios About Drug Development and Drug Pricing”, Health Care Knowledge Centre (KCE) Report 271, D/2016/10.273/59, Health Services Research (HSR), Brussels.

01 de juny 2023

Els venedors de fum i la regulació de pa-sucat-amb-oli

En Joan Font de Comediants va decidir celebrar els 50 anys del grup fent una obra amb el títol "El venedor de fum", una història personal reflectint tot el que ha estat la trajectòria. És evident que en Joan Font és un venedor d'històries magnífiques que ens han omplert moltes hores de joia i distracció. Unes històries on l'audiència gaudia d'allò més bé. I si hagués de triar una obra de les moltes que van fer, jo diria "El llibre de les bèsties", l'obra magna de Ramon Llull posada en escena muda. Impressionant. Voldria tornar a veure-la.

Doncs bé, de venedors de fum amb altres consequències més preocupants en tenim molts. Ahir entrava a la presó per 11 anys Elizabeth Holmes pel cas Theranos, un gran frau diagnòstic basat a Silicon Valley. N'hem parlat molt aquí. Però hi ha altres venedors de fum que sota una aureola de certesa, seguretat i eficàcia, ofereixen una profunda incertesa que sovint no acaba qualificada pels tribunals com a frau. Això succeeix quan el regulador no ha fet bé la seva feina (i els tribunals tampoc) i ja ho vaig explicar pel cas dels diagnòstics in vitro fa 6 anys. Doncs bé ara que ja és efectiva la regulació ja podem veure el desgavell que es produeix. En temps de pandèmia es va fer evident. Resulta que de les noves proves per detecció de Sars-COV-2 no en sabíem a Europa la sensibilitat i especificitat, arribaven amb una marca CE que fan uns organismes i que no serveix per saber la magnitud dels falsos positius i negatius. La solució era esperar que la FDA digués quina era la sensibilitat i especificitat d'una prova per tal de comprar-la. Tot això, en general, la gent del carrer ho desconeixia i ho desconeix, només intuïa que hi havia resultats que no eren certs i que si els feien dues vegades no sortia el mateix.

Ara que ja ha passat la pandèmia, tenim el mateix problema però agreujat. Les empreses han après que la regulació de pa sucat amb oli europea és una oportunitat a explotar. I dic això perquè veig una febre de comercialització de noves proves diagnòstiques sense cap avaluació independent i que quan hi ha una dada de sensibilitat i especificitat resulta que només és publicada principalment pels empleats o accionistes de l'empresa que les fabrica. I ara volen que els mateixos que han subvencionat la recerca siguin els seus clients. I ja hem tancat el cercle. I si voleu hi podem afegir la caixa negra de les patents i ja ho tenim tot. Just avui que hi ha tres països que passen de llarg de la nova regulació europea de patents, sabeu quins són? Democràcies plenes i modernes: Polònia, Croàcia i Espanya. I si voleu podem afegir que han patentat privadament les proves diagnòstiques quan han disposat de finançament públic. I aquí m'aturo. L'últim que tanqui el llum i la porta.

'Pseudomnesia

09 de març 2023

Una de les fites més grans de la ciència: mRNA i les vacunes

La vacuna. La carrera para desarrollar una vacuna contra la COVID-19

Elegimos ir a la Luna. Crónica desde dentro de cómo se hizo posible lo imposible

The Messenger: Moderna, the Vaccine, and the Business Gamble That Changed the World

Just he acabat de llegir aquests tres llibres que fan referència a la vacuna BionTech-Pfizer i ModeRNA pel SARS-CoV-2. Primer va BionTech, per un motiu elemental són els que tenien el coneixement i el que va passar es que no van fer com a ModeRNA que alhora es van dedicar a la fabricació. Pfizer va ser capaç de posar-la al mercat en temps record. I va primer de tot BionTech perquè és la persistència en la recerca la que els ha portat a aquest resultat extraordinari en temps i efectivitat. Començant per comprendre els fonaments i després per encapsular l'mRNA que codifica la proteïna S en nanopartícules lipídiques i així crear anticossos neutralitzants al virus SARS-CoV-2.

Aquesta és una de les grans fites que ha assolit la ciència en un temps molt curt. És cert, però portaven més d'una dècada treballant-hi sense cap producte al mercat. I mentrestant uns inversors alemanys seguien apostant per ells.

El cas de ModeRNA és molt similar. Tenen un enfocament clavat en el potencial del mRNA i el desenvolupen en càncer, però no assoleixen cap producte al mercat després d'una dècada. A diferència de BionTech, el govern nordamericà va donar-los moltes subvencions.

Al darrera de BionTech i ModeRNA hi ha un personatge que surt a tots els llibres i és clau per l'èxit, Barney Graham. Des de l'Institut de Malalties Infeccioses nord-americà és capaç d'oferir-los guiatge i suport. Crec que ell sol es mereixeria un llibre.

Ara passada la pandèmia comença la lluita de les patents. ModeRNA reclama a BionTech perquè diuen que ha utilitzat coneixement que havien patentat abans. I ja hi som. El que hi ha en joc és molt, perquè el nombre de patents és elevat i el mRNA seria una via molt exitosa d'afrontar nous tractaments per càncer i moltes més malalties. Crec que haurien d'aprendre del que va passar amb els anticossos monoclonals, ho vaig explicar fa temps.

Tres llibres fonamentals i recomanables per comprendre què significa mRNA i com hem arribat on som, sans i estalvis (encara que no tots, gairebé 7 milions de morts per COVID), i alhora és moment d'un reconeixement als inversors que van apostar per la recerca a llarg termini i que va justament en contra dels resultats a curt que espera Wall Street.

Després de llegir aquests llibres pensava com tant poca gent ha aconseguit fer tant per la humanitat. Gent amb un talent immens, fruit d'un esforç i persistència continuada.

PD. El que he escrit sobre vacunes.

02 de maig 2023

El penya-segat de les patents

Ens trobem en moments d'incertesa per la propera pèrdua de patents a la indústria farmacèutica. No és pas nou, fa una dècada ja en vaig parlar perquè va passar exactament el mateix. Ara caldrà veure quina és la reacció. I la millor forma de resoldre el futur, és comprar-lo. Així és. Si no has fet els deures en R+D o si els has fet i fracassat, aleshores el que et queda es comprar medicaments potencials en fase II que permetin sortir airosos de la situació. Elemental. Just això és el que alguns estan decidint i comprant a preus desmesurats ara mateix. La factura la pagarem després tots plegats.